Diabetes management partner interface for wireless communication of analyte data

ABSTRACT

Systems, devices, and methods are disclosed for wireless communication of analyte data. In embodiments, a method of using a diabetes management partner interface to configure an analyte sensor system for wireless communication with a plurality of partner devices is provided. The method includes the analyte sensor system receiving authorization to provide one of the partner devices with access to a set of configuration parameters via the diabetes management partner interface. The set of configuration parameters is stored in a memory of the analyte sensor system. The method also includes, responsive to input received from the one partner device via the diabetes management partner interface, the analyte sensor system setting or causing a modification to the set of configuration parameters, according to a system requirement of the one partner device.

INCORPORATION BY REFERENCE TO RELATED APPLICATION

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application claims the benefit of U.S. ProvisionalApplication No. 62/579,061, filed Oct. 30, 2017. The aforementionedapplication is incorporated by reference herein in its entirety, and ishereby expressly made a part of this specification.

TECHNICAL FIELD

The present disclosure relates generally to an interface for thewireless communication of analyte data gathered using an analyte sensorsystem. More particularly, the present disclosure is directed tosystems, methods, apparatuses, and devices, for using a diabetesmanagement partner interface to improve the flexibility an analytesensor system in wireless communications with a display device, amedical device, and/or other (e.g., electronic) devices.

BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which causes an arrayof physiological derangements (kidney failure, skin ulcers, or bleedinginto the vitreous of the eye) associated with the deterioration of smallblood vessels. A hypoglycemic reaction (low blood sugar) may be inducedby an inadvertent overdose of insulin, or after a normal dose of insulinor glucose-lowering agent accompanied by extraordinary exercise orinsufficient food intake.

Conventionally, a diabetic person carries a self-monitoring bloodglucose (SMBG) monitor, which may require uncomfortable finger prickingmethods. Due to the lack of comfort and convenience, a diabetic willnormally only measure his or her glucose level two to four times perday. Unfortunately, these time intervals are spread so far apart thatthe diabetic will likely be alerted to a hyperglycemic or hypoglycemiccondition too late, sometimes incurring dangerous side effects as aresult. In fact, it is not only unlikely that a diabetic will take atimely SMBG value, but will not know if his blood glucose value is goingup (higher) or down (lower), due to limitations of conventional methods.

Consequently, a variety of non-invasive, transdermal (e.g.,transcutaneous) and/or implantable electrochemical sensors are beingdeveloped for continuously detecting and/or quantifying blood glucosevalues. These devices generally transmit raw or minimally processed datafor subsequent analysis at a remote device, which can include a display.The transmission to wireless display devices can be wireless. The remotedevice can then provide the user with information about the user's bloodglucose levels. Because systems using such implantable sensors canprovide more up to date information to users, they may reduce the riskof a user failing to regulate the user's blood glucose levels.Nevertheless, such systems typically still rely on the user to takeaction in order to regulate the user's blood glucose levels, for exampleby making an injection.

Certain devices have been introduced to automate regulation of users'blood glucose levels. The introduction of such devices can create issuesof interoperability issues with other devices that may be employed forblood glucose monitoring (e.g., the remote device described above),particularly for example where the aforementioned devices are deployedby a different manufacturers. For example, the device introduced forautomatic blood glucose level regulation may be subject to certainrequirements regarding interference, battery life, accuracy andreliability, and so forth. Such requirements may not be known in advanceby the manufacturer of the monitoring device, and/or it may be desirablein some cases to change the requirements from time to time, includingbased on ecosystem configurations such as the available networkconnections, number of connected devices, etc. In addition, with anincreasing number of electronic devices becoming network connectable,more devices can be used to manage health conditions such as diabetes.But maintaining synchronized analyte data communication among multipledevices, while useful, has become increasingly more difficult for users.

Accordingly, conventional systems are not well-suited for the deploymentand integration of devices for monitoring blood glucose levels andadditional devices for regulating blood glucose levels, particularlywhere such devices are offered by various manufacturers, where suchdevices communicate wirelessly over various types of communicationnetworks and/or media, and where a particular level of flexibilityand/or adaptability is desirable.

SUMMARY

A first aspect of the present disclosure includes a method of using adiabetes management partner interface to configure an analyte sensorsystem for wireless communication with a plurality of partner devices.The method includes the analyte sensor system receiving authorization toprovide one of the partner devices with access to a set of configurationparameters via the diabetes management partner interface. The set ofconfiguration parameters is stored in a memory of the analyte sensorsystem. The method also includes, responsive to input received from theone partner device via the diabetes management partner interface, theanalyte sensor system setting or causing a modification to the set ofconfiguration parameters, according to a system requirement of the onepartner device.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the one partner device is anautomatic insulin delivery device or a manual insulin delivery device.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of configurationparameters includes one or more of a set of wireless connectivityparameters, a set of access control parameters, and a set of analytedata parameters.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the system requirement isassociated with one of: a battery capacity of the one partner device; anaccuracy requirement of the one partner device; a communication protocolused by the one partner device; a regulatory requirement applicable tothe one partner device; and an expected operational time of the onepartner device.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of wirelessconnectivity parameters includes a condition under which the one partnerdevice is to be removed from a whitelist maintained for the analytesensor system. In embodiments, the analyte sensor system setting orcausing the modification to the set of configuration parametersaccording to the system requirement of the one partner device includesthe analyte sensor system setting the condition such that the onepartner device is to be removed from the whitelist when a battery levelof the one partner delivery device meets a threshold.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of wirelessconnectivity parameters includes an advertisement structure. Inembodiments, the analyte sensor system setting or causing themodification to the set of configuration parameters according to thesystem requirement of the one partner device includes the analyte sensorsystem using the diabetes management partner interface to set or modifythe advertisement structure.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of access controlparameters includes one or more of: a number of display devices that theanalyte sensor system may connect to; and a level of access or controlthe analyte sensor system may give to one or more of the displaydevices.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of analyte dataparameters includes a calibration period for the analyte sensor system.In embodiments, the analyte sensor system setting or causing themodification to the set of configuration parameters according to thesystem requirement of the one partner device includes the analyte sensorsystem using the diabetes management partner interface to set or modifythe calibration period.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of analyte dataparameters includes a factory calibration code. In embodiments, theanalyte sensor system uses the diabetes management partner interface toreceive from the one partner device an indication to use the factorycalibration code, according to the system requirement of the one partnerdevice. The analyte sensor system setting or causing the modification tothe set of configuration parameters according to the system requirementof the one partner device may include the analyte sensor system usingthe diabetes management partner interface to set or modify thecalibration period to zero or none.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of wirelessconnectivity parameters includes settings in a remote server. Theanalyte sensor system setting or causing the modification to the set ofconfiguration parameters according to the system requirement of the onepartner device may include using the diabetes management partnerinterface to configure the analyte sensor to perform a number ofoperations. Such operations may include the use of services provided viathe remote server. Such operations may include, responsive to servicesprovided via the remote server, transmitting diabetes managementfeedback to one or more display devices connected to the analyte sensorsystem. Such operations may include, if the services provided via theremote server become unavailable, disabling the use of the services andsend a related notification to display devices connected to the analytesensor system.

In certain implementations of the first aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the first aspect, the set of analyte dateparameters includes bolus calculation parameters. In embodiments, theanalyte sensor system setting or causing the modification to the set ofconfiguration parameters according to the system requirement of the onepartner device includes the analyte sensor system using the diabetesmanagement partner interface to provide the one partner device withaccess to the bolus calculation parameters. In embodiments, the methodalso includes the analyte sensor system providing a bolus recommendationbased on a calculation performed using the bolus calculation parameters.

A second aspect of the present disclosure includes an analyte sensorsystem for wireless communication with a plurality of partner devices.The analyte sensor system is configurable by use of a diabetesmanagement partner interface. The analyte sensor system includes ananalyte sensor used to generate analyte information. The analyte sensorsystem includes a transceiver adapted to transmit and receive wirelesssignals. Further, the analyte sensor system includes a memory to store aset of configuration parameters used by the transceiver to transmit andreceive the wireless signals. The analyte sensor system also includescircuitry operatively coupled to the transceiver and the memory andadapted to cause the analyte sensor system to perform a number ofoperations. Such operations include, receiving authorization to provideone of the partner devices with access to a set of configurationparameters via the diabetes management partner interface. Suchoperations include, responsive to input received from the one partnerdevice via the diabetes management partner interface, setting or causinga modification to the set of configuration parameters, according to asystem requirement of the partner device.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the one partner device is anautomatic insulin delivery device or a manual insulin delivery device.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of configurationparameters comprises one or more of a set of wireless connectivityparameters, a set of access control parameters, and a set of analytedata parameters.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the system requirement isassociated with one of: a battery capacity of the one partner device; anaccuracy requirement of the one partner device; a communication protocolused by the one partner device; a regulatory requirement applicable tothe one partner device; and an expected operational time of the onepartner device.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of wirelessconnectivity parameters includes a condition under which the one partnerdevice is to be removed from a whitelist maintained for the analytesensor system. In embodiments, the circuitry is further adapted to causethe analyte sensor system to set the condition such that the one partnerdevice is to be removed from the whitelist when a battery level of theone partner delivery device meets a threshold, according to the systemrequirement of the one partner device.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of wirelessconnectivity parameters includes an advertisement structure. Inembodiments, the circuitry is further adapted to cause the analytesensor system to use the diabetes management partner interface to set ormodify the advertisement structure.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of access controlparameters comprises one or more of: a number of display devices thatthe analyte sensor system may connect to; and a level of access orcontrol the analyte sensor system may give to one or more of the displaydevices.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of analyte dataparameters comprises a calibration period for the analyte sensor system.In embodiments, the circuitry is further adapted to cause the analytesensor system to use the diabetes management partner interface to set ormodify the calibration period.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of analyte dataparameters comprises a factory calibration code. In embodiments, thecircuitry is further adapted to cause the analyte sensor system to usethe diabetes management partner interface to receive from the onepartner device an indication to use the factory calibration code,according to the system requirement of the one partner device. Inembodiments, the circuitry is further adapted to cause the analytesensor system to use the diabetes management partner interface to set ormodify the calibration period to zero or none.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of wirelessconnectivity parameters includes settings in a remote server. Inembodiments, the circuitry is further adapted to cause the analytesensor system to use the diabetes management partner interface toconfigure the analyte sensor to perform additional operations. One suchoperation is to use services provided via the remote server. One suchoperation is to, responsive to services provided via the remote server,transmit diabetes management feedback to one or more display devicesconnected to the analyte sensor system. One such operation is to, if theservices provided via the remote server become unavailable, disable theuse of the services and send a related notification to display devicesconnected to the analyte sensor system.

In certain implementations of the second aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the second aspect, the set of analyte dateparameters includes bolus calculation parameters. In embodiments, thecircuitry is further adapted to cause the analyte sensor system to usethe diabetes management partner interface to configure the analytesensor system to provide the one partner device with access to the boluscalculation parameters, according to the system requirement of thepartner device. In embodiments, the circuitry is further adapted tocause the analyte sensor to provide a bolus recommendation based on acalculation performed using the bolus calculation parameters.

A third aspect of the present disclosure includes a system. The systemincludes one or more partner devices adapted to deliver insulin to auser. The system includes an analyte sensor system adapted to generateanalyte information. The analyte sensor system includes a set ofconfiguration parameters used to transmit and receive wireless signals.The configuration parameters are configurable by use of a diabetesmanagement partner interface. The system also includes a display deviceconnectable to the analyte sensor system and adapted to display analyteinformation and to provide authorization for the analyte sensor systemto provide one of the partner devices with access to the set ofconfiguration parameters via the diabetes management partner interface.The one partner devices is adapted to use the diabetes managementpartner interface to set or cause a modification to the set ofconfiguration parameters, according to a system requirement of thepartner device.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the one partner device is anautomatic insulin delivery device or a manual insulin delivery device.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of configurationparameters includes one or more of a set of wireless connectivityparameters, a set of access control parameters, and a set of analytedata parameters.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the system requirement isassociated with one of: a battery capacity of the one partner device; anaccuracy requirement of the one partner device; a communication protocolused by the one partner device; a regulatory requirement applicable tothe one partner device; and an expected operational time of the onepartner device.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of wirelessconnectivity parameters includes a condition under which the one partnerdevice is to be removed from a whitelist maintained for the analytesensor system. In embodiments, the one partner device is further adapteduse the diabetes management partner interface to set or modify thecondition such that the one partner device is to be removed from thewhitelist when a battery level of the one partner delivery device meetsa threshold, according to the system requirement of the one partnerdevice.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of wirelessconnectivity parameters includes an advertisement structure. Inembodiments, the one partner device is further adapted to use thediabetes management partner interface to set or modify the advertisementstructure.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of access controlparameters includes one or more of: a number of display devices that theanalyte sensor system may connect to; and a level of access or controlthe analyte sensor system may give to one or more of the displaydevices.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of analyte dataparameters includes a calibration period for the analyte sensor system.In embodiments, the one partner device is further adapted to use thediabetes management partner interface to set or modify the calibrationperiod.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of analyte dataparameters includes a factory calibration code. In embodiments, the onepartner device is further adapted to use the diabetes management partnerinterface to: provide the analyte sensor system with an indication touse the factory calibration code, according to the system requirement ofthe one partner device; and to set or modify the calibration period tozero or none.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of wirelessconnectivity parameters includes settings in a remote server. Inembodiments, the one partner device is further adapted to use thediabetes management partner interface to configure the analyte sensor toperform a number of operations. The one partner device is furtheradapted to use services provided via the remote server. The one partnerdevice is further adapted to, responsive to services provided via theremote server, transmit diabetes management feedback to display deviceconnectable to the analyte sensor system. The one partner device isfurther adapted to, if the services provided via the remote serverbecome unavailable, disable the use of the services and send a relatednotification to the display device connectable to the analyte sensorsystem.

In certain implementations of the third aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the third aspect, the set of analyte dateparameters includes bolus calculation parameters. In embodiments, theone partner device is further adapted to use the diabetes managementpartner interface to configure the analyte sensor system to provide theone partner device with access to the bolus calculation parameters,according to the system requirement of the partner device. Inembodiments, the one partner device is further adapted to use thediabetes management partner interface receive from the analyte sensorsystem a bolus recommendation based on a calculation performed using thebolus calculation parameters.

A fourth aspect of the present disclosure includes a method of using adiabetes management partner interface to configure wirelesscommunications among an analyte sensor system and one or more of adisplay device and a partner device. The method includes an analytesensor system enabling a first wireless signal communication path. Thefirst wireless communication signal path is between the analyte sensorsystem and the display device. For the first wireless communicationpath, the analyte sensor system provides the display device with a firstdegree of access or control over the analyte sensor system. The methodalso includes the analyte sensor system enabling a second wirelesssignal communication path. The second wireless signal communication pathis between the analyte sensor system and the partner device. The analytesensor system enabling the second wireless signal communication pathincludes causing a modification to the first degree of access or controlin order to implement a second degree of access or control according toa system requirement of the partner device. The modification is causedin response to input received from the partner device via the diabetesmanagement partner interface.

In certain implementations of the fourth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fourth aspect, causing the modification tothe first degree of access or control includes using the diabetesmanagement partner interface to set or change a set of configurationparameters implemented by the analyte sensor system, in accordance withthe system requirement of the partner device.

In certain implementations of the fourth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fourth aspect, the set of configurationparameters includes one or more of access control parameters for thedisplay device or the partner device, accuracy or calibration parametersfor the analyte sensor system, and wireless communication parameters forcommunications to be exchanged among the analyte sensor system and oneor more of the display device and the partner device.

In certain implementations of the fourth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fourth aspect, using the diabetes managementpartner interface to set or change the set of configuration parametersincludes granting to the partner device permission to configure theaccuracy or calibration parameters for the analyte sensor system via thediabetes management partner interface.

In certain implementations of the fourth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fourth aspect, using the diabetes managementpartner interface to set or change the set of configuration parametersincludes revoking from the display device permission to configure theaccuracy or calibration parameters for the analyte sensor.

In certain implementations of the fourth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fourth aspect, the access control parametersinclude a whitelist for devices connectable to the analyte sensorsystem. The method may also include using the diabetes managementpartner interface to set or change the set of configuration parameterscomprises setting or modifying an amount of time the partner device isto remain on the whitelist before being removed from the whitelist.

A fifth aspect of the present disclosure includes an analyte sensorsystem for wireless communication with one or more of a display deviceand a partner device. The analyte sensor system is configurable by useof a diabetes management partner interface. The analyte sensor systemincludes a memory to store a set of configuration parameters used by atransceiver to transmit and receive the wireless signals. The analytesensor system also includes circuitry operatively coupled to thetransceiver and the memory and adapted to cause the analyte sensorsystem to perform a number of operations. One such operation is toenable a first wireless signal communication path. The first wirelesscommunication signal path is between the analyte sensor system and thedisplay device. For the first wireless communication path, the analytesensor system provides the display device with a first degree of accessor control over the analyte sensor system. Another such operation is toenable a second wireless signal communication path. The second wirelesssignal communication path is between the analyte sensor system and thepartner device. The second wireless signal communication path is enabledby a modification made by the analyte sensor system to the first degreeof access or control. The modification to the first degree of access orcontrol is made in response to input received from the partner devicevia the diabetes management partner interface. The modification to thefirst degree of access or control is made in order to implement a seconddegree of access or control according to a system requirement of thepartner device.

In certain implementations of the fifth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fifth aspect, in order to make themodification to the first degree of access or control, the circuitry isfurther adapted to cause the analyte sensor system to use the diabetesmanagement partner interface to set or change a set of configurationparameters implemented by the analyte sensor system, in accordance withthe system requirement of the partner device.

In certain implementations of the fifth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fifth aspect, the set of configurationparameters includes one or more of access control parameters for thedisplay device or the partner device, accuracy or calibration parametersfor the analyte sensor system, and wireless communication parameters forcommunications to be exchanged among the analyte sensor system and oneor more of the display device and the partner device.

In certain implementations of the fifth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fifth aspect, the circuitry is furtheradapted to cause the analyte sensor system to grant to the partnerdevice permission to configure the accuracy or calibration parametersfor the analyte sensor system via the diabetes management partnerinterface.

In certain implementations of the fifth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fifth aspect, the circuitry is furtheradapted to cause the analyte sensor system to revoke from the displaydevice permission to configure the accuracy or calibration parametersfor the analyte sensor.

In certain implementations of the fifth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the fifth aspect, the access control parametersinclude a whitelist for devices connectable to the analyte sensorsystem. In embodiments, the circuitry is further adapted to set ormodify an amount of time the partner device is to remain on thewhitelist before being removed from the whitelist.

A sixth aspect of the present disclosure includes a method of using adiabetes management partner interface for an analyte sensor system tocontrol wireless communications among the analyte sensor system and oneor more remote devices connectable to the analyte sensor system. The oneor more remote devices include a display device and a partner device.The method includes the analyte sensor system determining whether aconnection request received from one of the remote devices originatedfrom a partner class within the one or more remote devices. The remotedevices in the partner class are adapted to provide medicaments. Thepartner class includes the partner device. The method includes, if theconnection request originated from the partner class, the diabetesmanagement partner interface enabling selection of an operating modecorresponding to the partner class. In order to support a systemrequirement of the partner device, the operating mode uses a set ofconfiguration parameters for the partner class.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the method includes exchangingthe wireless communications with at least one of the remote devicesusing the operating mode corresponding to the partner class.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, exchanging the wirelesscommunications using the operating mode corresponding to the partnerclass includes transmitting a mode indicator usable by the at least oneof the remote devices to determine the operating mode being used.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the set of configurationparameters used to support the system requirement of the partner deviceincludes one or more of access control parameters for the display deviceor the partner device, accuracy or calibration parameters for theanalyte sensor system, and wireless communication parameters forcommunications to be exchanged among the analyte sensor system and oneor more of the remote devices.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the mode indicator is operableby the analyte sensor system to use the diabetes management partnerinterface to deactivate access by a set of the remote devices that arenot in the partner class to one or more of the access controlparameters, the accuracy or calibration parameters, and the wirelesscommunication parameters. In embodiments, access to the one or more ofthe access control parameters, the accuracy or calibration parameters,and the wireless communication parameters by the set of remote devicesis activated when the analyte sensor system uses an operating modecorresponding to the set of remote devices.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the method also includesdetermining that the analyte sensor system has not received a wirelesscommunication from the partner device for at least a predeterminedamount of time. The method also includes, in response to thedetermining, and further in response to receiving a connection requestfrom one of the remote devices in a set of the remote devices that arenot in the partner class, the analyte sensor system selecting anoperating mode corresponding to the set of the remote devices that arenot in the partner class. The operating mode corresponding to the set ofremote devices that are not in the partner class follows a set ofconfiguration parameters specific to the set of remote devices that arenot in the partner class. In embodiments, the method also includesremoving the partner device from a whitelist.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the method includes theanalyte sensor system using the diabetes management partner interface toreceive from the partner device a value for one of the configurationparameters. The method also includes the analyte sensor system modifyingthe one configuration parameter using the value received from thepartner device.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the method includes theanalyte sensor system sending the value for the configuration parameterto the display device. The value includes one or more of: a specifiedtime after which the partner device is to be removed from a white listmaintained for the analyte sensor system; and a specified time afterwhich the display device is to be removed from the whitelist.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, exchanging the wirelesscommunications using the operating mode corresponding to the partnerdevice includes one or more of: modifying a white list maintained forthe analyte sensor system in order to switch off slots for devices otherthan the partner device; and transmitting advertisement messagesdirected to only the partner device.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the method includes, if theconnection request did not originate from the partner class, the analytesensor system selecting an operating mode corresponding to a set of theremote devices that are not in the partner class. The operating modecorresponding to the set of remote devices that are not in the partnerclass uses a set of configuration parameters specific to the set of theremote devices that are not in the partner class.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, the display device is in theset of remote devices that are not in the partner class. In embodiments,the method further includes using the diabetes management partnerinterface to provide the display device with access to the set ofconfiguration parameters specific to the set of the remote devices thatare not in the partner class. The method may further include the analytesensor system setting or modifying a value for one of the configurationparameters specific to the set of the remote devices that are not in thepartner class, responsive to input received from the display device.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, exchanging the wirelesscommunications using the operating mode corresponding to the partnerclass includes modifying advertisement slots to advertise only for a thepartner device or a partner device controller.

In certain implementations of the sixth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the sixth aspect, exchanging the wirelesscommunications using the operating mode corresponding to the partnerclass includes: responsive to a command received via the diabetesmanagement partner interface, the analyte sensor system accepting onlyconnection requests received from the partner device. The command may bereceived from the partner device.

A seventh aspect of the present disclosure includes an analyte sensorsystem that uses a diabetes management partner interface to controlwireless communications among the analyte sensor system and one or moreremote devices connectable to the analyte sensor system. The one or moreremote devices includes a display device and a partner device. Theanalyte sensor system includes circuitry operatively coupled to a memorythat stores instructions that, when executed, cause the analyte sensorsystem to perform a number of operations. One such operation is todetermine whether a connection request received from one of the remotedevices originated from a partner class within the one or more remotedevices. The remote devices in the partner class are adapted to providemedicaments. The partner class includes the partner device. Another suchoperation is to, if the connection request originated from the partnerclass, use the diabetes management partner interface to enable selectionof an operating mode corresponding to the partner class. In order tosupport a system requirement of the partner device, the operating modeuses a set of configuration parameters for the partner class.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system toexchange the wireless communications with at least one of the remotedevices using the operating mode corresponding to the partner class.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the wireless communicationsexchanged using the operating mode corresponding to the partner classinclude a mode indicator sent by the analyte sensor system to the atleast one of the remote devices. The mode indicator is usable by the atleast one of the remote devices to determine the operating mode beingused.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the set of configurationparameters used to support the system requirement of the partner deviceincludes one or more of access control parameters for the display deviceor the partner device, accuracy or calibration parameters for theanalyte sensor system, and wireless communication parameters forcommunications to be exchanged among the analyte sensor system and oneor more of the remote devices.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the mode indicator isoperable by the analyte sensor system to use the diabetes managementpartner interface to deactivate access by a set of the remote devicesthat are not in the partner class to one or more of the access controlparameters, the accuracy or calibration parameters, and the wirelesscommunication parameters. In embodiments, the memory further storesinstructions that, when executed, cause the analyte sensor system toprovide access to the one or more of the access control parameters, theaccuracy or calibration parameters, and the wireless communicationparameters by the set of remote devices when the analyte sensor systemuses an operating mode corresponding to the set of remote devices.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system toperform additional operations. One such operation is to make adetermination that the analyte sensor system has not received a wirelesscommunication from the partner device for at least a predeterminedamount of time. Another such operation is to, in response to thedetermination, and further in response to a connection request receivedfrom one of the remote devices in a set of the remote devices that arenot in the partner class, select an operating mode corresponding to theset of the remote devices that are not in the partner class. Theoperating mode corresponding to the set of remote devices that are notin the partner class follows a set of configuration parameters specificto the set of remote devices that are not in the partner class.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system toremove the partner device from a whitelist.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system toperform additional operations. One such operation is to use the diabetesmanagement partner interface to receive from the partner device a valuefor one of the configuration parameters. Another such operation is tomodify the one configuration parameter using the value received from thepartner device.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system tosend the value for the configuration parameter to the display device.The value includes one or more of: a specified time after which thepartner device is to be removed from a white list maintained for theanalyte sensor system; and a specified time after which the displaydevice is to be removed from the whitelist.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system toperform additional operations. One such operation is to modify a whitelist maintained for the analyte sensor system in order to switch offslots for devices other than the partner device. Another such operationis to transmit advertisement messages directed to only the partnerdevice.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to: ifthe connection request did not originate from the partner class, selectan operating mode corresponding to a set of the remote devices that arenot in the partner class, wherein the operating mode corresponding tothe set of remote devices that are not in the partner class uses a setof configuration parameters specific to the set of the remote devicesthat are not in the partner class.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the display device is in theset of remote devices that are not in the partner class, and wherein thememory further stores instructions that, when executed, cause theanalyte sensor system to perform additional operations. One suchoperation is to use the diabetes management partner interface to providethe display device with access to the set of configuration parametersspecific to the set of the remote devices that are not in the partnerclass. Another such operation is to set or modify a value for one of theconfiguration parameters specific to the set of the remote devices thatare not in the partner class, responsive to input received from thedisplay device.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system tomodify advertisement slots to advertise only for a the partner device ora partner device controller.

In certain implementations of the seventh aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the seventh aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to:responsive to a command received via the diabetes management partnerinterface, accept only connection requests received from the partnerdevice. The command may be received from the partner device.

A eighth aspect of the present disclosure includes a method of using adiabetes management interface to allow configurability of an analytesensor system that exchanges wireless communications with one or more ofa partner device and a display device. The method includes the analytesensor system determining that a first connection request was sent froma remote device in a first class of remote devices. The method includesthe analyte sensor system determining that a second connection requestwas sent from a remote device in a second class of remote devices. Theremote devices of the second class of remote devices are adapted todeliver medicaments. The remote devices of the first class of remotedevices do not belong to the second class of remote devices. The methodincludes the analyte sensor system using any one of a plurality ofoperating modes. A first operating mode of the plurality is specific toa first configuration that utilizes a remote device in the second classof remote devices and does not utilize a remote device in the firstclass of remote devices. A second operating mode of the plurality isspecific to a second configuration that does not utilize a device fromthe second class of remote devices. A third operating mode of theplurality is specific to a third configuration that utilizes a remotedevice in the first class of remote devices and a remote device from thesecond class of remote devices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, using the first operatingmode of the plurality includes providing the remote device in the secondclass of remote devices authority to use the diabetes management partnerinterface to modify permissions provided to the remote device in thefirst class of remote devices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, using the first operatingmode of the plurality further includes the analyte sensor systemreceiving from the remote device in the first class of remote devices anauthentication for the remote device in the second class of remotedevices to communicate with the analyte sensor system.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, using the first operatingmode further includes, responsive to input received via the diabetesmanagement partner device from the remote device in the second class ofremote devices, the analyte sensor system preventing a connection withdevices other than the remote device in the second class of remotedevices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, preventing the connectionincludes using a first advertisement slot to advertise to the remotedevice in the second class of remote devices. Preventing the connectionalso includes using a second advertisement slot to advertise to theremote device in the second class of remote devices or a controller forthe remote device in the second class of remote devices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, preventing the connectionincludes the analyte sensor system using the diabetes management partnerinterface to set or cause a modification to an advertisement structureto include a single advertisement duration dedicated to the remotedevice in the second class of devices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, preventing the connectionincludes the analyte sensor system accepting connection requests fromonly the remote device in the second class of remote devices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, using the first operatingmode of the plurality further includes the analyte sensor system usinginput received from the remote device in the second class of remotedevices via the diabetes management interface to modify timeout rulesassociated with the remote device in the second class of remote devices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, using the second operatingmode of the plurality includes one or more of the following operations:modifying a whitelist to exclude the remote device in the second classof remote devices; rejecting connection requests received from theremote device in the second class of remote devices; and advertisingexclusively for remote devices in the first class of remote devices.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, using the third operatingmode of the plurality includes the analyte sensor system receiving, viathe diabetes management interface, an indication from the remote devicein the second class of remote devices of a level of access to theanalyte sensor system that the remote device in the first class ofremote devices is to be given.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, the method includes theanalyte sensor system using the diabetes management interface toimplement the level of access. The method also includes notifying theremote device in the first class of remote devices of the level ofaccess.

In certain implementations of the eighth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the eighth aspect, according to the level ofaccess, the remote device in the first class of remote devices canreceive analyte data from the analyte sensor system but cannot accessaccuracy or calibration parameters used by the analyte sensor system forthe third operating mode.

A ninth aspect of the present disclosure includes an analyte sensorsystem that exchanges wireless communications with one or more of apartner device and a display device. The analyte sensor system isconfigurable by way of a diabetes management partner interface. Theanalyte sensor system includes circuitry operatively coupled to a memorythat stores instructions that, when executed, cause the analyte sensorsystem to perform a number of operations. One such operation is todetermine that a first connection request was sent from a remote devicein a first class of remote devices. Another such operation is todetermine that a second connection request was sent from a remote devicein a second class of remote devices. The remote devices of the secondclass of remote devices are adapted to deliver medicaments. The remotedevices of the first class of remote devices do not belong to the secondclass of remote devices. Another such operation is to use any one of aplurality of operating modes. A first operating mode of the plurality isspecific to a first configuration that utilizes a remote device in thesecond class of remote devices and does not utilize a remote device inthe first class of remote devices. A second operating mode of theplurality is specific to a second configuration that does not utilize adevice from the second class of remote devices. A third operating modeof the plurality is specific to a third configuration that utilizes aremote device in the first class of remote devices and a remote devicefrom the second class of remote devices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to, inthe first operating mode of the plurality, provide the remote device inthe second class of remote devices authority to use the diabetesmanagement partner interface to modify permissions provided to theremote device in the first class of remote devices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to, inthe first operating mode of the plurality, receive from the remotedevice in the first class of remote devices an authentication for theremote device in the second class of remote devices to communicate withthe analyte sensor system.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to, inthe first operating mode of the plurality: responsive to input receivedvia the diabetes management partner device from the remote device in thesecond class of remote devices, prevent a connection with devices otherthan the remote device in the second class of remote devices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to usea first advertisement slot to advertise to the remote device in thesecond class of remote devices; and use a second advertisement slot toadvertise to the remote device in the second class of remote devices ora controller for the remote device in the second class of remotedevices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to usethe diabetes management partner interface to set or cause a modificationto an advertisement structure to include a single advertisement durationdedicated to the remote device in the second class of devices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system toaccept connection requests from only the remote device in the secondclass of remote devices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to, inthe first operating mode of the plurality, use input received from theremote device in the second class of remote devices via the diabetesmanagement interface to modify timeout rules associated with the remotedevice in the second class of remote devices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to, inthe second operating mode of the plurality, perform additionaloperations. One such operation is to modify a whitelist to exclude theremote device in the second class of remote devices. Another suchoperation is to reject connection requests received from the remotedevice in the second class of remote devices. Another such operation isto advertise exclusively for remote devices in the first class of remotedevices.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to, inthe third operating mode of the plurality, receive, via the diabetesmanagement interface, an indication from the remote device in the secondclass of remote devices of a level of access to the analyte sensorsystem that the remote device in the first class of remote devices is tobe given.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, the memory further storesinstructions that, when executed, cause the analyte sensor system to:use the diabetes management interface to implement the level of access;and notify the remote device in the first class of remote devices of thelevel of access.

In certain implementations of the ninth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the ninth aspect, according to the level ofaccess, the remote device in the first class of remote devices canreceive analyte data from the analyte sensor system but cannot accessaccuracy or calibration parameters used by the analyte sensor system forthe third operating mode.

A tenth aspect of the present disclosure includes a method of using adiabetes management interface to facilitate the exchange of wirelesscommunications with an analyte sensor system. The method includes usingthe diabetes management partner interface to establish a firstconnection between the analyte sensor system and a first partner device.The method includes the analyte sensor system providing the firstpartner device with access to a set of configuration parameters via thediabetes management interface. The method further includes setting orcausing a first modification to the set of configuration parameters inresponse to input received from the first partner device via thediabetes management partner interface. Setting or causing the firstmodification is done according to a system requirement of the firstpartner device. Additionally, the method includes using the diabetesmanagement partner interface to establish a second connection betweenthe analyte sensor system and a second partner device. The method alsoincludes the analyte sensor system providing the second partner devicewith access to the set of configuration parameters via the diabetesmanagement interface. The method further includes causing a secondmodification to the set of configuration parameters in response to inputreceived from the second partner device via the diabetes managementpartner interface. The second modification is done according to a systemrequirement of the second partner device.

In certain implementations of the tenth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the tenth aspect, using the diabetes managementpartner interface to establish the second connection occurs after thefirst connection has been terminated.

In certain implementations of the tenth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the tenth aspect, the method further includes,responsive the analyte sensor system receiving identificationinformation for a third partner device, using the diabetes managementpartner interface to attempt to establish a third connection between theanalyte sensor system and the third partner device. The method alsoincludes, responsive to establishing the third connection between theanalyte sensor system and a third partner device, causing a thirdmodification to the set of configuration parameters in response to inputreceived via the diabetes management partner interface. The thirdmodification is done according to a system requirement of the thirdpartner device.

In certain implementations of the tenth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the tenth aspect, the identification informationfor the third partner device is stored in a server system. Inembodiments, the identification information indicates whether the thirdpartner device is authorized to communicate with the analyte sensorsystem.

In certain implementations of the tenth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the tenth aspect, the analyte sensor systemreceiving the identification information for the third partner deviceincludes the analyte sensor system receiving the identificationinformation for the third partner device from a display device thatreceived the identification information for the third partner devicefrom the server system.

In certain implementations of the tenth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the tenth aspect, the method includes additionaloperations. One such operation involves, responsive the analyte sensorsystem receiving the identification information for the third partnerdevice, using the identification information for the third partnerdevice to determine whether the third partner device is authorized tocommunicate with the analyte sensor system. Another such operationinvolves, responsive to determining that the third partner device is notauthorized to communicate with the analyte sensor system, denying theattempt to establish the third connection between the analyte sensorsystem and the third partner device. Another such operation involves,responsive to determining that the third partner device is authorized tocommunicate with the analyte sensor system, using the diabetesmanagement partner interface to establish the third connection betweenthe analyte sensor system and the third partner device.

In certain implementations of the tenth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the tenth aspect, determining that the thirdpartner device is not authorized to communicate with the analyte sensorsystem occurs at a first time. In embodiments, determining that thethird partner device is authorized to communicate with the analytesensor system occurs at a second time. The identification informationfor the third partner device may be updated at the server system betweenthe first time and the second time.

In certain implementations of the tenth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the tenth aspect, the system requirement for thethird partner device is stored in a server system. The method furtherincludes causing a fourth modification to the set of configurationparameters in response to input received via the diabetes managementpartner interface. The fourth modification is made according to anupdated version of the system requirement of the third partner device.

A eleventh aspect of the present disclosure includes an analyte sensorsystem that uses a diabetes management interface to facilitate theexchange of wireless communications. The analyte sensor system includescircuitry operatively coupled to a memory that stores instructions that,when executed, cause the analyte sensor system to perform a number ofoperations. One such operation is to use the diabetes management partnerinterface to establish a first connection between the analyte sensorsystem and a first partner device. Another such operation is to providethe first partner device with access to a set of configurationparameters via the diabetes management interface. Another such operationis to set or cause a first modification to the set of configurationparameters in response to input received from the first partner devicevia the diabetes management partner interface. The first modification ismade according to a system requirement of the first partner device.Another such operation is to use the diabetes management partnerinterface to establish a second connection between the analyte sensorsystem and a second partner device. Another such operation is to providethe second partner device with access to the set of configurationparameters via the diabetes management interface. Yet another suchoperation is to cause a second modification to the set of configurationparameters in response to input received from the second partner devicevia the diabetes management partner interface. The second modificationis made according to a system requirement of the second partner device.

In certain implementations of the eleventh aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the eleventh aspect, the secondconnection is established after the first connection has beenterminated.

In certain implementations of the eleventh aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the eleventh aspect, the memory furtherstores instructions that, when executed, cause the analyte sensor systemto perform additional operations. One such operation is to receiveidentification information for a third partner device. Another suchoperation is to, responsive to the identification information for thethird partner device being received, use the diabetes management partnerinterface to attempt to establish a third connection between the analytesensor system and the third partner device. Another such operation isto, responsive to the third connection between the analyte sensor systemand a third partner device being established, cause a third modificationto the set of configuration parameters in response to input received viathe diabetes management partner interface. The third modification ismade according to a system requirement of the third partner device.

In certain implementations of the eleventh aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the eleventh aspect, the identificationinformation for the third partner device is stored in a server system.The identification information indicates whether the third partnerdevice is authorized to communicate with the analyte sensor system.

In certain implementations of the eleventh aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the eleventh aspect, the memory furtherstores instructions that, when executed, cause the analyte sensor systemto receive the identification information for the third partner devicefrom a display device that received the identification information forthe third partner device from the server system.

In certain implementations of the eleventh aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the eleventh aspect, the memory furtherstores instructions that, when executed, cause the analyte sensor systemto perform additional operations. One such operation is to, responsivethe identification information for the third partner device beingreceived, use the identification information for the third partnerdevice to determine whether the third partner device is authorized tocommunicate with the analyte sensor system. Another such operation isto, responsive to a determination that the third partner device is notauthorized to communicate with the analyte sensor system, deny theattempt to establish the third connection between the analyte sensorsystem and the third partner device. Another such operation is to,responsive to a determination that the third partner device isauthorized to communicate with the analyte sensor system, use thediabetes management partner interface to establish the third connectionbetween the analyte sensor system and the third partner device.

In certain implementations of the eleventh aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the eleventh aspect, the determinationthat the third partner device is not authorized to communicate with theanalyte sensor system is made at a first time. In embodiments, thedetermination that the third partner device is authorized to communicatewith the analyte sensor system is made at a second time. In embodiments,the identification information for the third partner device is updatedat the server system between the first time and the second time.

In certain implementations of the eleventh aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the eleventh aspect, the systemrequirement for the third partner device is stored in a server system.The memory further stores instructions that, when executed, cause theanalyte sensor system to cause a fourth modification to the set ofconfiguration parameters in response to input received via the diabetesmanagement partner interface. The fourth modification is made accordingto an updated version of the system requirement of the third partnerdevice.

A twelfth aspect of the present disclosure includes a method. The methodincludes an analyte sensor system receiving an indication to enter anoperating mode specific to use of a partner device. The method furtherincludes establishing a connection between the analyte sensor system andthe partner device. The method also includes the analyte sensor systemsetting or modifying configuration parameters responsive to inputreceived from the partner device via a diabetes management partnerinterface. The input received from the partner device indicatescorresponding operating parameters to be used by the partner device tocommunicate with the analyte sensor system using the operating mode. Theconfiguration parameters are configured in accordance with a systemrequirement of the partner device. The method also includes implementingthe operating mode specific to the use of the partner device using theoperating parameters of the analyte sensor system, such that the systemrequirement of the partner device is accommodated.

In certain implementations of the twelfth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the twelfth aspect, the configuration parametersinclude one or more of: permission parameters for a display devices toissue a command or control signal to start, stop, calibrate, or set thelength of a sensor session for the analyte sensor system; battery orpower management parameters; connection model parameters; timeoutparameters, wherein one or more of the timeout parameters relates to alength of time to keep the partner device on a whitelist, advertisingtimeout, connection establishment timeout, and authorization timeout;alert parameters; configuration settings governing operating modes forthe analyte sensor system; and remote server parameters.

In certain implementations of the twelfth aspect, which may be generallyapplicable but are also particularly applicable in connection with anyother implementation of the twelfth aspect, the method further includesthe analyte sensor system receiving an indication to transition fromimplementing in the operating mode specific to the use of the partnerdevice. Further, the method includes the analyte sensor system restoringthe configuration parameters to a previous state that existed beforesetting or modifying the configuration parameters responsive to theinput received from the partner device. Restoring the set ofconfiguration parameters to the previous state may include removing thepartner device from a whitelist.

A thirteenth aspect of the present disclosure includes a method. Themethod includes an analyte sensor system determining whether a wirelesscommunication system includes one or more of a display device and apartner device. The method also includes, if the wireless communicationsystem includes the display device, the analyte sensor systemdetermining whether to connect to the display device using one of anintermittent connection model and a continuous connection model. Themethod further includes, if the system includes the partner device, theanalyte sensor system determining whether to connect to the partnerdevice using one of the intermittent connection model the continuousconnection model. The analyte sensor system determining which of theintermittent or continuous connection models will be used for connectingto one or more of the display device and the partner device includesusing configuration parameters that have been set or modified usinginput receiving from the partner device via a diabetes managementpartner interface.

In certain implementations of the thirteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the thirteenth aspect, the analytesensor system determining to connect to the partner device according tothe intermittent connection model is done using one of the configurationparameters that has been set responsive to a power requirement of thepartner device.

In certain implementations of the thirteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the thirteenth aspect, the analytesensor system determining to connect to the partner device according tothe continuous connection model is done using the determination that thesystem includes the display device.

A fourteenth aspect of the present disclosure includes a method. Themethod includes an analyte sensor application of a display devicereceiving an interface to a partner device application associated with apartner device. The method includes the analyte sensor application usingthe interface to collect information gathered by the partner deviceapplication. The information includes one or more of pairing data andanalyte dosage data. The method also includes the analyte sensorapplication using the interface to provide analyte sensor systeminformation. The analyte sensor information is used to indicate one ormore of the following: that the analyte sensor system is functioning; aconnection model employed by the analyte sensor system in regards to thepartner device or the display device; and configuration parameters usedby the analyte sensor system to communicate with one or more of thepartner device and the display device.

In certain implementations of the fourteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fourteenth aspect, the methodfurther includes the analyte sensor application receiving analyte datafrom the analyte sensor system. The method also includes the analytesensor application providing a visual display that includes the analytedata and the information gathered by the partner device application.

In certain implementations of the fourteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fourteenth aspect, the method alsoincludes the analyte sensor application receiving information regardinganalyte values from the analyte sensor system. The method also includesthe analyte sensor application using the interface to communicate theanalyte values to the partner device via the partner device application.

In certain implementations of the fourteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fourteenth aspect, the method alsoincludes the analyte sensor application receiving, via the interface,medicament delivery information gathered by the partner device.

In certain implementations of the fourteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fourteenth aspect, the method alsoincludes the analyte sensor application receiving, via the interface, analert from the partner device. The alert relates to a problem with thefunctionality of the partner device.

In certain implementations of the fourteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fourteenth aspect, the method alsoincludes the analyte sensor application of the display device causingthe alert to be provided via a user interface.

In certain implementations of the fourteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fourteenth aspect, the method alsoincludes the analyte sensor application of the display device causingthe alert to be provided via a remote server.

A fifteenth aspect of the present disclosure includes a method. Themethod includes establishing a connection between an analyte sensorsystem and a partner device. The method further includes the analytesensor system using a diabetes management partner interface to receiveconfiguration parameter information from the partner device. Theconfiguration parameter information relates to operation of the analytesensor system in accordance with a system requirement of the partnerdevice. The configuration parameter information may include a degree ofaccess to be given to a remote device connectable to the analyte sensorsystem. The configuration parameter information may include one or morevalues for a set of configurability parameters used for connectionsestablished between the analyte sensor system and the partner device.The one or more values for the set of configurability parameters areselected in accordance with the system requirement of the partnerdevice.

In certain implementations of the fifteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fifteenth aspect, the set ofconfigurability parameters includes one or more of the following. Theset of configurability parameters may include connection information forthe remote device. The set of configurability parameters may include aconnection model to be used for a particular device connectable to theanalyte sensor system. The set of configurability parameters may includeconnection command related data to be read by or sent to the remotedevice. The set of configurability parameters may include informationrelated to non-use of the partner device. The set of configurabilityparameters may include security or privacy related parameters. The setof configurability parameters may include information related to powercontrol or battery usage. The set of configurability parameters mayinclude a number of devices connectable to the analyte sensor system.The set of configurability parameters may include a device type of eachdevice connectable to the analyte sensor system. The set ofconfigurability parameters may include a type of information related toanalyte data that may be read by and sent to remote devices connectableto the analyte sensor system.

In certain implementations of the fifteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fifteenth aspect, the connectioncommand related data indicates one or more of the following. Theconnection command related data may indicate whether the partner deviceor the remote device is eligible for inclusion on a whitelist for theanalyte sensor system. The connection command related data may indicatewhether the partner device or the remote device is adapted to age offthe whitelist. If the partner device or the remote device is adapted toage off the whitelist, the connection command related data may indicatean amount of time before the partner device or the remote device is setto age off the whitelist.

In certain implementations of the fifteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fifteenth aspect, the informationrelated to power control includes a suggestion to age off particulardevices to extend battery life for the analyte sensor system.

In certain implementations of the fifteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fifteenth aspect, the informationrelated to power control or battery usage is gathered via a controlmechanism that balances battery life of the analyte sensor systemagainst connection reliability as between the analyte sensor system andthe partner device or the remote device.

In certain implementations of the fifteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fifteenth aspect, the informationrelated to power control triggers a low power mode for the analytesensor system.

In certain implementations of the fifteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the fifteenth aspect, the degree ofaccess is received only after the analyte sensor system has receivedauthorization for the degree of access to be modified using theparameter information received from the partner device.

A sixteenth aspect of the present disclosure includes a method. Themethod includes establishing a connection between a display device andan analyte sensor system. The method also includes the display devicereceiving an indication that the analyte sensor system is connecting toa partner device. The method also includes, after receivingauthorization to provide the partner device with access to a set ofconfiguration parameters via a diabetes management partner interface,receiving, via the diabetes management partner interface, configurationparameters for alerts originating from the partner device. The methodalso includes the display device providing a user interface to configurealerts originating from the analyte sensor system and the alertsoriginating from the partner device. The method further includes usinginput received via the user interface to cause a modification to theconfiguration parameters for the alerts originating from the partnerdevice. The modification is made in accordance with a system requirementof the partner device.

In certain implementations of the sixteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the sixteenth aspect, the method alsoincludes receiving, via the user interface, a selection of the partnerdevice or a remote device of a plurality of remote devices that includesthe display device, to be used as a primary device for providing one ormore of the alerts originating from the analyte sensor system and thealerts originating from the partner device.

In certain implementations of the sixteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the sixteenth aspect, the method alsoincludes providing the alerts on a device other than the primary devicein the event a battery capacity of the primary device falls below athreshold.

In certain implementations of the sixteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the sixteenth aspect, the method alsoincludes the display device receiving, via the user interface, aselection of respective alerts types to be provided for the alertsoriginating from the partner device and for the alerts originating fromthe analyte sensor system.

In certain implementations of the sixteenth aspect, which may begenerally applicable but are also particularly applicable in connectionwith any other implementation of the sixteenth aspect, the method alsoincludes providing the alerts via a primary notification device. Themethod also includes, if no acknowledgment is received in response toproviding the alerts via the primary notification device, providing thealerts via a secondary notification device. The primary and secondarynotification devices are the partner device, the analyte sensor system,and/or at least one of the plurality of remote devices.

A sixteenth aspect of the present disclosure includes a method formonitoring an operability status of a medicament delivery device. Themethod includes receiving, from the medicament delivery device,medicament delivery device information related to one or more of thefollowing. The medicament delivery device information may be related toreservoir changes. The medicament delivery device information may berelated to pump rewind. The medicament delivery device information maybe related to pump prime. The medicament delivery device information maybe related to cannula fill. The medicament delivery device informationmay be related to fluid pressure. The medicament delivery deviceinformation may be related to determining a combination of themedicament delivery device information with analyte data generated usingthe analyte sensor system. The medicament delivery device informationmay be related to the analyte sensor system using the combination todetermine the operability status of the medicament delivery device.

BRIEF DESCRIPTION OF THE DRAWINGS

Further aspects of the present disclosure will be more readilyappreciated upon review of the detailed description of the variousdisclosed embodiments, described below, when taken in conjunction withthe accompanying figures.

FIG. 1 illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 2A illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 2B illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 3A is a perspective view of an example enclosure that may be usedin connection with implementing embodiments of an analyte sensor system.

FIG. 3B is a side view of an example enclosure that may be used inconnection with implementing embodiments of an analyte sensor system.

FIG. 3C illustrates aspects of an example analyte sensor systemaccording to embodiments of the disclosure.

FIG. 4 illustrates aspects of an example display device according toembodiments of the disclosure.

FIG. 5A illustrates aspects of an example partner device according toembodiments of the disclosure.

FIG. 5B illustrates aspects of an example partner device according toembodiments of the disclosure.

FIG. 6 is a timing diagram illustrating aspects of advertisementmessages that may be transmitted in accordance with embodiments of thepresent disclosure.

FIG. 7A is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 7B is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 7C is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 7D illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 8 illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 9A illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 9B is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9C is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9D is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9E is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9F is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9G is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9H is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9J is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9K is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9L is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9M is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9N is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9P is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9Q is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9R is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 9S is an operational flow diagram illustrating various operationsthat may be performed in accordance with embodiments of the disclosure.

FIG. 10A illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 10B illustrates aspects of an example system that may be used inconnection with implementing embodiments of the disclosure.

FIG. 11 illustrates an example computing module in accordance withembodiments of the present disclosure.

The figures are described in greater detail in the description andexamples below, are provided for purposes of illustration only, andmerely depict typical or example embodiments of the disclosure. Thefigures are not intended to be exhaustive or to limit the disclosure tothe precise form disclosed. It should also be understood that thedisclosure may be practiced with modification or alteration, and thatthe disclosure may be limited only by the claims and the equivalentsthereof.

DETAILED DESCRIPTION

Embodiments of the present disclosure are directed to systems, methods,and devices for wireless communication of analyte data, as well as aninterface for the wireless communication of analyte data gathered usingan analyte sensor system. In various deployments described herein, theanalyte data is glucose data generated by an analyte sensor systemconfigured to connect to display devices, partner devices (e.g., medicaldevices such as an insulin pump), and the like. Implementing aspects ofthe present disclosure, including more particularly, the systems,methods, apparatuses, and devices described herein that use a diabetesmanagement partner interface, may improve the flexibility of the analytesensor system in wireless communications with a display device, one ormore partner devices, and/or other (e.g., electronic) devices.

Moreover, implementing aspects of the present disclosure may also allowfor improving performance with respect to the reliability, speed, andaccuracy of wireless communications, including vis-à-vis partner devicesand display devices (e.g., where the foregoing devices may bemanufactured by various third-parties), as well as the connectionprotocols and configurations associated therewith. Additionally, in somecases, system requirements such as those related to accuracy, powerconsumption, or reliability may be less critical, and in such cases,different configurations and modes of connection may be employed tooptimize or adapt system performance. In particular, some aspects of thedisclosure relate to, for example, setting or modifying connectionparameters of an analyte sensor system based on, among other factors,system requirements of a partner device.

The details of some example embodiments of the systems, methods, anddevices of the present disclosure are set forth in this description andin some cases, in other portions of the disclosure. Other features,objects, and advantages of the disclosure will be apparent to one ofskill in the art upon examination of the present disclosure,description, figures, examples, and claims. It is intended that all suchadditional systems, methods, devices, features, and advantages beincluded within this description (whether explicitly or by reference),be within the scope of the present disclosure, and be protected by oneor more of the accompanying claims.

A. System Overview & Example Configurations

FIG. 1 depicts system 100 that may be used in connection withembodiments of the present disclosure that involve gathering,monitoring, and/or providing information regarding analyte valuespresent in a user's body, including for example the user's blood glucosevalues. System 100 depicts aspects of analyte sensor system 8 that maybe communicatively coupled to display devices 110, 120, 130, and 140,partner devices 136, and/or server system 134.

Analyte sensor system 8 in the illustrated embodiment includes sensorelectronics module 12 and continuous analyte sensor 10 associated withsensor electronics module 12. Sensor electronics module 12 may be inwireless communication (e.g., directly or indirectly) with one or moreof display devices 110, 120, 130, and 140. In addition or alternativelyto display devices 110, 120, 130, and 140, sensor electronics module 12may be in wireless communication (e.g., directly or indirectly) withpartner devices 136 and/or server system 134. Likewise, in someexamples, display devices 110-140 may additionally or alternatively bein wireless communication (e.g., directly or indirectly) with partnerdevices 136 and/or server system 134. Various couplings shown in FIG. 1can be facilitated with wireless access point 138, as also mentionedbelow.

In certain embodiments, sensor electronics module 12 includes electroniccircuitry associated with measuring and processing the continuousanalyte sensor data, including prospective algorithms associated withprocessing and calibration of the sensor data. Sensor electronics module12 can be physically connected to continuous analyte sensor 10 and canbe integral with (non-releasably attached to) or releasably attachableto continuous analyte sensor 10. Sensor electronics module 12 mayinclude hardware, firmware, and/or software that enables measurement oflevels of the analyte via a glucose sensor. For example, sensorelectronics module 12 can include a potentiostat, a power source forproviding power to the sensor, other components useful for signalprocessing and data storage, and a telemetry module for transmittingdata from the sensor electronics module to one or more display devices.Electronics can be affixed to a printed circuit board (PCB), or thelike, and can take a variety of forms. For example, the electronics cantake the form of an integrated circuit (IC), such as anApplication-Specific Integrated Circuit (ASIC), a microcontroller,and/or a processor.

Sensor electronics module 12 may include sensor electronics that areconfigured to process sensor information, such as sensor data, andgenerate transformed sensor data and displayable sensor information.Examples of systems and methods for processing sensor analyte data aredescribed in more detail herein and in U.S. Pat. Nos. 7,310,544 and6,931,327 and U.S. Patent Publication Nos. 2005/0043598, 2007/0032706,2007/0016381, 2008/0033254, 2005/0203360, 2005/0154271, 2005/0192557,2006/0222566, 2007/0203966 and 2007/0208245, all of which areincorporated herein by reference in their entireties.

With further reference to FIG. 1, display devices 110, 120, 130, and/or140 can be configured for displaying (and/or alarming) the displayablesensor information that may be transmitted by sensor electronics module12 (e.g., in a customized data package that is transmitted to thedisplay devices based on their respective preferences). Each of displaydevices 110, 120, 130, or 140 can (respectively) include a display suchas touchscreen display 112, 122, 132, /or 142 for displaying sensorinformation and/or analyte data to a user and/or receiving inputs fromthe user. For example, a graphical user interface may be presented tothe user for such purposes. In embodiments, the display devices mayinclude other types of user interfaces such as voice user interfaceinstead of or in addition to a touchscreen display for communicatingsensor information to the user of the display device and/or receivinguser inputs. In embodiments, one, some, or all of display devices 110,120, 130, 140 may be configured to display or otherwise communicate thesensor information as it is communicated from sensor electronics module12 (e.g., in a data package that is transmitted to respective displaydevices), without any additional prospective processing required forcalibration and real-time display of the sensor data.

The plurality of display devices 110, 120, 130, 140 depicted in FIG. 1may include a custom display device, for example, analyte display device110, specially designed for displaying certain types of displayablesensor information associated with analyte data received from sensorelectronics module 12 (e.g., a numerical value and/or an arrow, inembodiments). In embodiments, one of the plurality of display devices110, 120, 130, 140 includes a smartphone, such as mobile phone 120,based on an Android, iOS, or other operating system, and configured todisplay a graphical representation of the continuous sensor data (e.g.,including current and/or historic data). Other display devices 110, 120,130, 140 can include other hand-held devices, such as tablet 130, smartwatch 140, partner devices 136 (e.g., an insulin delivery device,whether automatic or manual, or a blood glucose meter), a smart fridge,a vehicle, a smart mirror, a smart clock, a smart drink, an implantableinsulin delivery device, and/or a desktop or laptop computer.

Because different display devices 110, 120, 130, 140 etc. and partnerdevice(s) 136 can provide different user interfaces, content of the datapackages (e.g., amount, format, and/or type of data to be displayed,alarms, and the like) can be customized (e.g., programmed differently bythe manufacture and/or by an end user) for each particular displaydevice 110, 120, 130, 140 etc. and/or partner device(s) 136.Accordingly, in embodiments, a plurality of different display devices110, 120, 130, 140 can be in direct wireless communication with sensorelectronics module 12 (e.g., such as an on-skin sensor electronicsmodule that is physically connected to continuous analyte sensor 10)during a sensor session to enable a plurality of different types and/orlevels of display and/or functionality associated with the displayablesensor information, which is described in more detail elsewhere herein.

As further illustrated in FIG. 1 and mentioned above, system 100 mayalso include wireless access point (WAP) 138 that may be used to coupleone or more of analyte sensor system 8, the plurality display devices110, 120, 130, 140 etc., server system 134, and medical device 136 toone another. For example, WAP 138 may provide WiFi and/or cellular orother wireless connectivity within system 100. Near Field Communication(NFC) may also be used among devices of system 100. Server system 134may be used to collect analyte data from analyte sensor system 8 and/orthe plurality of display devices, for example, to perform analyticsthereon, generate universal or individualized models for glucose levelsand profiles, provide services or feedback, including from individualsor systems remotely monitoring the analyte data, and so on.

Referring now to FIG. 2A, system 200 is depicted. System 200 may be usedin connection with implementing embodiments of the disclosed systems,methods, apparatuses, and/or devices, including for example aspectsdescribed above in connection with FIG. 1. By way of example, variousbelow-described components of FIG. 2A may be used to provide wirelesscommunication of analyte (e.g., glucose) data, for example among/betweenanalyte sensor system 308, display devices 310, partner devices 315,and/or one or more server systems 334, and so on.

As shown in FIG. 2A, system 200 may include analyte sensor system 308,one or more display devices 310, and/or one or more partner devices 315.Additionally, in the illustrated embodiment, system 200 includes serversystem 334, which in turn includes server 334 a coupled to processor 334c and storage 334 b. Analyte sensor system 308 may be coupled to displaydevices 310, partner devices 315, and/or server system 334 viacommunication media 305. Many details of the processing, gathering, andexchanging of data, and/or executing actions (e.g., providingmedicaments or related instructions) by analyte sensor system 308,partner devices 315, and/or display device 310, etc., are providedbelow.

As will be described in detail herein, analyte sensor system 308,display devices 310, and/or partner devices 315 may exchange messaging(e.g., control signaling) via communication media 305, and communicationmedia 305 may also be used to deliver analyte data to display devices310, partner devices 315, and/or server system 334. As alluded to above,display devices 310 may include a variety of electronic computingdevices, such as, for example, a smartphone, tablet, laptop, wearabledevice, etc. Display devices 310 may also include analyte display device110 customized for the display and conveyance of analyte data andrelated notifications etc. Partner devices 315 may include medicaldevices, such as an insulin pump or pen, connectable devices, such as asmart fridge or mirror, key fob, and other devices.

In embodiments, communication media 305 may be based on one or morewireless communication protocols, such as for example Bluetooth,Bluetooth Low Energy (BLE), ZigBee, WiFi, IEEE 802.11 protocols,Infrared (IR), Radio Frequency (RF), 2G, 3G, 4G, 5G, etc., and/or wiredprotocols and media. It will also be appreciated upon studying thepresent disclosure that communication media can be implemented as one ormore communication links, including in some cases, separate links,between the components of system 200, whether or not such links areexplicitly shown in FIG. 2A or referred to in connection therewith. Byway of illustration, analyte sensor system 308 may be coupled to displaydevice 310 via a first link of communication media 305 using BLE, whiledisplay device 310 may be coupled to server system 334 by a second linkof communication media 305 using a cellular communication protocol(e.g., 4G LTE).

In embodiments, the elements of system 200 may be used to performoperations of various processes described herein and/or may be used toexecute various operations and/or features described herein with regardto one or more disclosed systems and/or methods. Upon studying thepresent disclosure, one of skill in the art will appreciate that system200 may include single or multiple analyte sensor systems 308,communication media 305, and/or server systems 334.

As mentioned, communication media 305 may be used to connect orcommunicatively couple analyte sensor system 308, display devices 310,partner devices 315, and/or server system 334 to one another or to anetwork. Communication media 305 may be implemented in a variety offorms. For example, communication media 305 may include one or more ofan Internet connection, such as a local area network (LAN), a personarea network (PAN), a wide area network (WAN), a fiber optic network,internet over power lines, a hard-wired connection (e.g., a bus), DSL,and the like, or any other kind of network connection or communicativecoupling. Communication media 305 may be implemented using anycombination of routers, cables, modems, switches, fiber optics, wires,radio (e.g., microwave/RF, AM, FM links etc.), and the like. Further,communication media 305 may be implemented using various wirelessstandards, such as Bluetooth®, BLE, Wi-Fi, IEEE 802.11, 3GPP standards(e.g., 2G GSM/GPRS/EDGE, 3G UMTS/CDMA2000, or 4G LTE/LTE-A/LTE-U, 5G, orsubsequent generation), etc. Upon reading the present disclosure, one ofskill in the art will recognize other ways to implement communicationmedia 305 for communications purposes, and will also recognize thatcommunication media 305 may be used to implement features of the presentdisclosure using as of yet undeveloped communications protocols that maybe deployed in the future.

Further referencing FIG. 2A, server 334 a may receive, collect, and/ormonitor information, including analyte data, medicament data, andrelated information, from analyte sensor system 308, partner devices 315and/or display devices 310, such as input responsive to the analyte dataor medicament data, or input received in connection with an analytemonitoring application running on analyte sensor system 308 or displaydevice 310 (e.g., analyte application sensor application 425 a, withreference to FIG. 4), or a medicament delivery application running ondisplay device 310 or partner device 315 (e.g., medicament deliveryapplication 625, with reference to FIG. 5B). As such, server 334 a mayreceive, collect, and/or monitor information from partner devices 315,such as for example information related to the provision of medicamentsto a user and/or information regarding the operation of one or morepartner devices 315. Server 334 a also may receive, collect, and/ormonitor information regarding a user of analyte sensor system 308,display devices 310, and/or partner devices 315.

In embodiments, server 334 a may be adapted to receive such informationvia communication media 305. This information may be stored in storage334 b and may be processed by processor 334 c. For example, processor334 c may include an analytics engine capable of performing analytics oninformation that server 334 a has collected, received, etc. viacommunication media 305. In embodiments, server 334 a, storage 334 b,and/or processor 334 c may be implemented as a distributed computingnetwork, such as a Hadoop® network, or as a relational database or thelike. The aforementioned information may then be processed at server 334a such that services may be provided to analyte sensor system 308,display devices 310, and/or partner devices 315, and/or a user(s)thereof. For example, such services may include diabetes managementfeedback for the user.

Server 334 a may include, for example, an Internet server, a router, adesktop or laptop computer, a smartphone, a tablet, a processor, amodule, or the like, and may be implemented in various forms, including,for example, an integrated circuit or collection thereof, a printedcircuit board or collection thereof, or in a discretehousing/package/rack or multiple of the same. In embodiments, server 334a at least partially directs communications made over communicationmedia 305. Such communications may include the delivery of analyte data,medicament data, and/or messaging related thereto (e.g., advertisement,authentication, command, or other messaging). For example, server 334 amay process and exchange messages between and/or among analyte sensorsystem 308, display devices 310, and/or partner devices 315 related tofrequency bands, timing of transmissions, security/encryption, alarms,alerts, notifications, and so on. Server 334 a may update informationstored on analyte sensor system 308, partner devices 315, and/or displaydevices 310, for example, by delivering applications thereto or updatingthe same, and/or by reconfiguring system parameters or other settings ofanalyte sensor system 308, partner devices 315, and/or display devices310. Server 334 a may send/receive information to/from analyte sensorsystem 308, partner devices 315, and/or display devices 310 in realtime, periodically, sporadically, or on an event-drive basis. Further,server 334 a may implement cloud computing capabilities for analytesensor system 308, partner devices 315, and/or display devices 310.

Turning now to FIG. 2B, system 202 is depicted in accordance withembodiments of the present disclosure, some of which involve configuringand/or setting up a kind of mesh network for connecting various devicesdescribed herein. As shown, embodiments of system 202 include analytesensor system 308 communicatively coupled to one or more of displaydevices 310 a, 310 b and/or partner device 315 via communication media305. Display device 310 a may also be communicatively coupled to displaydevice 310 b via communication media 305 a. By way of example, FIG. 2Billustrates that in example implementations of the disclosure, displaydevice 310 a may connect to analyte sensor system 308 via communicationmedia 305 using a first connection scheme and a first wireless protocol(e.g., BLE). In turn, display device 310 a may also connect to displaydevice 310 b via communication media 305 a using a second connectionscheme and a second wireless protocol (e.g., Wi-Fi, NFC, etc.). Inembodiments, the connection between display device 310 a and analytesensor system 308 may subsequently be closed, and display device 310 bmay establish a connection with analyte sensor system 308 whilemaintaining the connection with display device 310 a. Further, forexample, display devices 310 a and 310 b may exchange analyte data withone another via communication media 305 a, where either or each displaydevice 310 a, 310 b received the analyte data via communication medium305, that is, from analyte sensor system 308.

Partner device 315 may also connect to display device 310 b viacommunication media 305 and/or communication media 305 b. Partner device315 may also connect to analyte sensor system 308 via communicationmedia 305. It will be appreciated that any number of differentconnection schemes/protocols may be employed for communicativelycoupling the components of system 202. For example, some networkconnections may be available intermittently, and/or may not be availableor preferable in some cases (due to device capabilities, geography,time, system conditions such as battery life or interferencerequirements, etc.). Thus, in some cases, partner device 315 may notdirectly connect to analyte sensor system 308, but rather may connectthereto indirectly via display device 310 b that may be connected toanalyte sensor system 308 via communication media 305. In some cases,display device 310 b may not directly connect to analyte sensor system308, but rather may connect thereto indirectly via partner device 315that may be connected to analyte sensor system 308 via communicationmedia 305. Additional aspects and features represented by FIG. 2B willbecome apparent upon studying the entirety of the present disclosure.

In embodiments, partner device 315 may not support a communicationprotocol utilized by analyte sensor system 308, and/or it may otherwisenot be preferable for partner device 315 to directly connect to analytesensor system 308. Thus, display device 310 (which in examples supportsa communication protocol utilized by analyte sensor system 308 and/ormay otherwise be more preferable for connection with analyte sensorsystem 308) may connect to analyte sensor system 308 and essentially actas a gateway device for partner device 315. As such, partner device 315may receive analyte data and the like indirectly from analyte sensorsystem 308, and/or may exchange or information therewith. In some cases,this may be referred to as tethering. It will also be appreciated thatin some cases partner device 315 may act as a gateway device for displaydevices 310 a, 310 b such that display device 310 a, 310 b can betethered and can receive analyte data from analyte sensor system 308 viapartner device 315. It will also be appreciated that in exampleimplementations of system 304, one or more display devices 310 a, 310 bcan be connected to analyte sensor system 308 in parallel with oneanother and/or in parallel or in series with one or more partner devices315. Each display device 310 a, 310 b and/or partner device 315 may alsohave connected thereto a chain of display devices 310 a, 310 b and/orpartner devices 315.

As alluded to above, wireless communication protocols may be used totransmit and receive analyte-related data, medicament-related data, andother messaging or information (e.g., control signaling and the like)among analyte sensor system 308, display device 310, partner device 315,and/or server system 334 via communication media 305. In embodiments,such wireless protocols may be designed for use in a wireless networkthat is optimized for periodic and small data transmissions (that may betransmitted at low rates if necessary) to and from multiple devices in aclose range (e.g., a personal area network). For example, one suchprotocol may be optimized for periodic data transfers where transceiversmay be configured to transmit data for shorter intervals and then enterlow power modes for longer intervals. The protocol may have low overheadrequirements both for normal data transmissions and for initiallysetting up communication channels (e.g., by reducing overhead) to reducepower consumption. In some embodiments, burst broadcasting schemes(e.g., one way communication) may be used. This may eliminate overheadrequired for acknowledgement signals and allow for periodictransmissions that consume little power. In other embodiments, passiveor active proximity-based protocols may be employed to reduce overhead(e.g., overhead associated with typical pairing operations) and/orincrease security, with NFC being one specific example.

The protocols may further be configured to establish communicationchannels with multiple devices while implementing interference avoidanceschemes. In some embodiments, the example protocol mentioned above maymake use of adaptive isochronous network topologies that define varioustime slots and frequency bands for communication with several devices.The protocol may thus modify transmission windows and frequencies inresponse to interference and to support communication with multipledevices. Accordingly, the wireless protocol may use time and frequencydivision multiplexing (TDMA/FDMA) based schemes. The wireless protocolmay also employ direct sequence spread spectrum (DSSS) andfrequency-hopping spread spectrum schemes. Various network topologiesmay be used to support short-distance and/or low-power wirelesscommunication such as peer-to-peer, start, tree, or mesh networktopologies, such as WiFi, Bluetooth, and BLE. The wireless protocol mayoperate in various frequency bands, such as for example an open ISM bandsuch as 2.4 GHz. Furthermore, to reduce power usage, the wirelessprotocol may adaptively configure data rates according to powerconsumption.

In embodiments relating to the configurations shown in FIG. 2B, a userinterface, such as a GUI provided by user interface 435 in FIG. 4, canpresent to the user information regarding the mesh network, such thatthe user may maintain some level of control and/or input into theconfiguration thereof. For example, the topography/topology of the meshnetwork might be provided, and the user may be enabled to accessconnection links to alter the connection model employed, the connectionparameters used, and/or the advertisement characteristics, etc.associated with the various connections. Moreover, the user may be ableto switch among display devices 310 and/or partner devices 315 in termsof which device can act as a gateway to other devices. Additionally, theuser, analyte sensor system 308, display device 315, and/or partnerdevice 315 may send control signaling to other networked elements inorder to manage the permissions/capabilities of other connected devices,and/or to manage the number/type of devices that can connect to analytesensor system 308 etc. In embodiments, display device 310 and/or partnerdevice 315 may be capable of managing the networktopography/configuration in an automated fashion based on, for example,system requirements of partner device 315. In order to facilitate suchautomated or semi-automated management, partner device 315 may haveaccess to mesh network configuration information via a diabetesmanagement partner interface, as described herein.

With the above description of aspects of the presently disclosed systemsand methods for wireless communication of analyte data, examples of somespecific features of the present disclosure will now be provided. Itwill be appreciated by one of skill in the art upon studying the presentdisclosure that these features may be implemented using aspects and/orcombinations of aspects of the example configurations described above,whether or not explicit reference is made to the same.

B. Analyte Data

Referring back to FIG. 1, as mentioned above, in embodiments, analytesensor system 8 is provided for continuous measurement of an analyte ina host or user. By way of an overview and an example, analyte sensorsystem 8 may be implemented as an encapsulated microcontroller thatmakes sensor measurements, generates analyte data (e.g., by calculatingvalues for continuous glucose monitoring data), and engages in wirelesscommunications (e.g., via Bluetooth and/or other wireless protocols) tosend such data to remote devices (e.g., display devices 110, 120, 130,140, partner devices 136, and/or server system 134).

Analyte sensor system 8 may include: continuous analyte sensor 10configured to continuously measure a concentration of the analyte in thehost, and sensor electronics module 12 that is typically physicallyconnected to continuous analyte sensor 10 during sensor use. Inembodiments, sensor electronics module 12 includes electronicsconfigured to process a data stream associated with an analyteconcentration measured by continuous analyte sensor 10, in order togenerate sensor information that includes raw sensor data, transformedsensor data, and/or any other sensor data, for example. Sensorelectronics module 12 may further be configured to generate sensorinformation that is customized for respective display devices 110, 120,130, 140, partner devices 136, and/or server system 134. Sensorelectronics module 12 may further be configured such that differentdevices may receive different sensor information, and may further beconfigured to wirelessly transmit sensor information to such displaydevices 110, 120, 130, 140, partner devices 136, and/or server system134.

The term “analyte” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a substance or chemicalconstituent in a biological fluid (for example, blood, interstitialfluid, cerebral spinal fluid, lymph fluid or urine) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, and/or reaction products. In someembodiments, the analyte for measurement by the sensor heads, devices,and methods is glucose. However, other analytes are contemplated aswell, including but not limited to acarboxyprothrombin; acylcarnitine;adenine phosphoribosyl transferase; adenosine deaminase; albumin;alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactiveprotein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholicacid; chloroquine; cholesterol; cholinesterase; conjugated 1-ßhydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MMisoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine;dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcoholdehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Beckermuscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A,hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F,D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax,sexual differentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free ß-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, ß);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferring;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte can be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbituates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body can also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC),Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and5-Hydroxyindoleacetic acid (FHIAA).

C. Analyte Sensor System

As alluded to above with reference to FIG. 1, in embodiments, analytesensor 10 includes a continuous glucose sensor, for example, asubcutaneous, transdermal (e.g., transcutaneous), or intravasculardevice. In embodiments, such a sensor or device can analyze a pluralityof intermittent blood samples. Analyte sensor 10 can use any method ofanalyte measurement, including for example glucose-measurement,including enzymatic, chemical, physical, electrochemical,spectrophotometric, polarimetric, calorimetric, iontophoretic,radiometric, immunochemical, and the like.

In embodiments where analyte sensor 10 is a glucose sensor, analytesensor 10 can use any method, including invasive, minimally invasive,and non-invasive sensing techniques (e.g., fluorescent monitoring), toprovide a data stream indicative of the concentration of glucose in ahost. The data stream is typically a raw data signal, which may beconverted into a calibrated and/or filtered data stream that can be usedto provide a useful value of glucose to a user, such as a patient or acaretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor,a nurse, or any other individual that has an interest in the wellbeingof the host).

A glucose sensor can be any device capable of measuring theconcentration of glucose. According to one example embodiment describedbelow, an implantable glucose sensor may be used. However, it should beunderstood that the devices and methods described herein can be appliedto any device capable of detecting a concentration of an analyte,glucose for example, and providing an output signal that represents theconcentration of the analyte, again glucose for example (e.g., as a formof analyte data).

In embodiments, analyte sensor 10 is an implantable glucose sensor, suchas described with reference to U.S. Pat. No. 6,001,067 and U.S. PatentPublication No. US-2005-0027463-A1. In embodiments, analyte sensor 10 isa transcutaneous glucose sensor, such as described with reference toU.S. Patent Publication No. US-2006-0020187-A1. In embodiments, analytesensor 10 is configured to be implanted in a host vessel orextracorporeally, such as is described in U.S. Patent Publication No.US-2007-0027385-A1, co-pending U.S. Patent Publication No.US-2008-0119703-A1 filed Oct. 4, 2006, U.S. Patent Publication No.US-2008-0108942-A1 filed on Mar. 26, 2007, and U.S. Patent ApplicationNo. US-2007-0197890-A1 filed on Feb. 14, 2007. In embodiments, thecontinuous glucose sensor includes a transcutaneous sensor such asdescribed in U.S. Pat. No. 6,565,509 to Say et al., for example. Inembodiments, analyte sensor 10 is a continuous glucose sensor thatincludes a subcutaneous sensor such as described with reference to U.S.Pat. No. 6,579,690 to Bonnecaze et al. or U.S. Pat. No. 6,484,046 to Sayet al., for example. In embodiments, the continuous glucose sensorincludes a refillable subcutaneous sensor such as described withreference to U.S. Pat. No. 6,512,939 to Colvin et al., for example. Thecontinuous glucose sensor may include an intravascular sensor such asdescribed with reference to U.S. Pat. No. 6,477,395 to Schulman et al.,for example. The continuous glucose sensor may include an intravascularsensor such as described with reference to U.S. Pat. No. 6,424,847 toMastrototaro et al., for example.

FIGS. 3A and 3B depict perspective and side views of enclosure 200 thatmay be used in connection with implementing embodiments of analytesensor system 8, according certain aspects of the present disclosure.Enclosure 200 includes mounting unit 214 and sensor electronics module12 attached thereto in certain embodiments. Enclosure 200 is shown in afunctional position, including mounting unit 214 and sensor electronicsmodule 12 matingly engaged therein. In embodiments, mounting unit 214,also referred to as a housing or sensor pod, includes base 234 adaptedfor fastening to a host's or user's skin. Base 234 can be formed from avariety of hard or soft materials, and can include a low profile forminimizing protrusion of the device from the host during use. Inembodiments, base 234 is formed at least partially from a flexiblematerial, which may provide numerous advantages over othertranscutaneous sensors, which, unfortunately, can suffer frommotion-related artifacts associated with the host's movement when thehost is using the device. Mounting unit 214 and/or sensor electronicsmodule 12 can be located over the sensor insertion site to protect thesite and/or provide a minimal footprint (utilization of surface area ofthe host's skin).

In embodiments, a detachable connection between mounting unit 214 andsensor electronics module 12 is provided, which may enable improvedmanufacturability, namely, the potentially relatively inexpensivemounting unit 214 can be disposed of when refurbishing or maintaininganalyte sensor system 8, while the relatively more expensive sensorelectronics module 12 can be reusable with multiple sensor systems. Inembodiments, sensor electronics module 12 is configured with signalprocessing (programming), for example, configured to filter, calibrate,and/or execute other algorithms useful for calibration and/or display ofsensor information. However, an integral (non-detachable) sensorelectronics module can be similarly configured.

In embodiments, contacts 238 are mounted on or in a subassemblyhereinafter referred to as contact subassembly 236 configured to fitwithin base 234 of mounting unit 214 and hinge 248 that allows contactsubassembly 236 to pivot between a first position (for insertion) and asecond position (for use) relative to mounting unit 214. The term“hinge” as used herein is a broad term and is used in its ordinarysense, including, without limitation, to refer to any of a variety ofpivoting, articulating, and/or hinging mechanisms, such as an adhesivehinge, a sliding joint, and the like; the term hinge does notnecessarily imply a fulcrum or fixed point about which the articulationoccurs. In embodiments, contacts 238 are formed from a conductiveelastomeric material, such as a carbon black elastomer, through whichsensor 10 extends.

With further reference to FIGS. 3A and 3B, in embodiments, mounting unit214 is provided with adhesive pad 208, disposed on the mounting unit'sback surface and includes a releasable backing layer. Thus, removing thebacking layer and pressing at last a portion of base 234 of mountingunit 214 onto the host's skin adheres mounting unit 214 to the host'sskin. Additionally or alternatively, an adhesive pad can be placed oversome or all of analyte sensor system 8 and/or sensor 10 after sensorinsertion is complete to ensure adhesion, and optionally to ensure anairtight seal or watertight seal around the wound exit-site (or sensorinsertion site) (not shown). Appropriate adhesive pads can be chosen anddesigned to stretch, elongate, conform to, and/or aerate the region(e.g., host's skin). Certain embodiments described with reference toFIGS. 2A and 2B are described in more detail with reference to U.S. Pat.No. 7,310,544, which is incorporated herein by reference in itsentirety. Configurations and arrangements can provide water resistant,waterproof, and/or hermetically sealed properties associated with themounting unit/sensor electronics module embodiments described herein.

Various methods and devices that are suitable for use in conjunctionwith aspects of embodiments described herein are disclosed in U.S.Patent Publication No. US-2009-0240120-A1, which is incorporated hereinby reference in its entirety.

Turning now to FIG. 3C, a more detailed functional block diagram ofanalyte sensor system 308 (discussed above for example in connectionwith FIGS. 2A, 2B) is provided. As shown in FIG. 3C, analyte sensorsystem 308 may include analyte sensor 535 (e.g., which may also bedesignated with the numeral 10 in FIG. 1) coupled to sensor measurementcircuitry 525 for processing and managing sensor data. Sensormeasurement circuitry 525 may be coupled to processor/microprocessor 530(e.g., which may be part of item 12 in FIG. 1). In some embodiments,processor 530 may perform part or all of the functions of sensormeasurement circuitry 525 for obtaining and processing sensormeasurement values from sensor 535.

Processor 530 may be further coupled to a radio unit or transceiver 510(e.g., which may be part of item 12 in FIG. 1) for sending sensor andother data and receiving requests and commands and other signaling froman external device, such as display device 310, which may be used todisplay or otherwise provide the sensor data (or analyte data) or dataderived therefrom to a user, server system 334, and/or partner device315, which may utilize sensor data or a derivative data derivedtherefrom in the administration of medicaments (e.g., insulin) and/ordiabetes management guidance to the user. As used herein, the terms“radio unit” and “transceiver” may be used interchangeably and generallyrefer to a device that can wirelessly transmit and receive data.

Analyte sensor system 308 may further include storage 515 (e.g., whichmay be part of item 12 in FIG. 1) and real time clock (RTC) 545 (e.g.,which may be part of item 12 in FIG. 1), for storing and tracking sensorand other data. For example, storage 515 may store configurationparameters 520. In general, configuration parameters 520 relate to theoperation of analyte sensor system 308, and in embodiments particularlyrelate to the operation of analyte sensor system 308 vis-à-vis partnerdevice 315 and/or display device 315. In embodiments, configurationparameters 520 may be accessed by partner device 315 (directly orindirectly) using diabetes management partner interface 550. In thismanner, configuration parameters 520 may be set and/or modifiedaccording to system requirements 650 (referencing FIG. 5B) of partnerdevice 315. For example, configuration parameters 520 may be modifiedsuch that analyte sensor system 308, display device 310, and/or partnerdevice 315 operate in such a way that one or more system requirements650 of partner device 315 are met.

As mentioned above, with further reference to FIG. 3C, embodiments ofanalyte sensor system 308 include diabetes management partner interface(DMPI) 550. Diabetes management partner interface 550 may allow partnerdevice 315 that is connected to analyte sensor system 308 to set and/orconfigure/modify configuration parameters 520 so that systemrequirements 650 of partner device 315 may be met in the operation ofanalyte sensor system 308, display device 310, and/or partner device315. DMPI 550 may provide partner device 315 access to configurationparameters 520 for the configuration of the same. Where partner devices315 and/or display devices 310 are offered by different manufacturersand have different design goals/constraints, DMPI 550 enables a flexiblesystem wherein configuration parameters 520 of analyte sensor system 308may be accessed, set, and/or modified according to the respective systemrequirements and/or design constraints of partner devices 315 and/ordisplay devices 310. This flexibility can improve the integration andinteroperability of such devices, resulting in a more usable andversatile ecosystem. Additional aspects of DMPI 550 will be discussedfurther below.

Although not expressly shown in FIG. 3C, embodiments of analyte sensorsystem 308 also include an interface specifically for display devices310 (as differentiated from partner device 315). This interface may be awireless interface that allows display device 310 to connect to analytesensor system 308 and access, set, and/or modify/configure configurationparameters 520 thereof in order to facilitate communications withanalyte sensor system 308. As will be discussed further in connectionwith FIGS. 10A and 10B, this interface may be part of or implementedwithin DMPI 550 (e.g., as DMPI 750 a) or may be separately implemented.In embodiments, the DMPI 550 is reconfigurable for accommodation ofcharacteristics of display devices 310 and/or partner devices 315 thatmay connect to analyte sensor system 308, as well as accommodation ofsystem-wide requirements and dynamics of, for example, system 200(referencing FIG. 2A).

Some components of analyte sensor system 308 may require replacementperiodically. For example, analyte sensor system 308 may include animplantable sensor 535 that may be attached to a sensor electronicsmodule that includes sensor measurement circuitry 525. Additionally,analyte sensor system 308 may include processor 530, storage 515, andtransceiver 510, and a battery (not shown). Sensor 535 may requireperiodic replacement (e.g., every 7 to 30 days). The sensor electronicsmodule may be configured to be powered and active for much longer thansensor 535 (e.g., for 3 to 6 months or more) until the battery needsreplacement. Replacing these components may be difficult and may requirethe assistance of trained personnel. Reducing the need to replace suchcomponents, particularly the battery, can significantly improve theconvenience and cost of using analyte sensor system 308, including tothe user. In embodiments, when a sensor electronics module is used forthe first time (or reactivated once a battery has been replaced in somecases), it may be connected to sensor 535 and a sensor session may beestablished. As will be further described below, there may be a processfor initially establishing communication between display device 310 andthe sensor electronics module when the module is first used orre-activated (e.g., after the battery is replaced). Once display device310 and the sensor electronics module have established communication,display device 310 and the sensor electronics module may periodicallyand/or continuously be in communication over the life of several sensors535 until, for example, the battery needs to be replaced. Each timesensor 535 is replaced, a new sensor session may be established. The newsensor session may be initiated through a process completed usingdisplay device 310 and the process may be triggered by notifications ofa new sensor 535 via the communication between the sensor electronicsmodule and display device 310 that may be persistent across sensorsessions.

Analyte sensor system 308 in example implementations gathers analytedata using sensor 535 and transmits the same or a derivative thereof todisplay device 310, partner device 315, and/or server system 334. Datapoints regarding analyte values may be gathered and transmitted over thelife of sensor 535. New measurements and/or related information may betransmitted often enough for a remote device/individual to adequatelymonitor analyte (e.g., glucose) levels.

It is to be appreciated that many details of the processing, gathering,and exchanging data by analyte sensor system 308, partner devices 315,and/or display device 310 etc. are provided elsewhere herein. It will beappreciated upon studying the present disclosure that analyte sensorsystem 308 may contain several like components that are described withrespect to FIGS. 4 and 5B, at least for some embodiments herein. Thedetails and uses of such like components may therefore be understoodvis-à-vis analyte sensor system 308 even if not expressly described herewith reference to FIG. 3C.

D. Display Devices

Referring by way of example again to FIG. 1, aspects of display devices110, 120, 130, and 140 that may be used in system 100 will now bedescribed. In embodiments of the present disclosure, sensor electronicsmodule 12 is configured to search for and/or attempt wirelesscommunication with a display device from a list of display devices. Byway of an overview and an example, a typical display device 110, 120,130, 140 can communicate wirelessly with analyte sensor system 8,including for authentication of display devices 110, 120, 130, 140and/or analyte sensor system 8, as well as the exchange of analyte dataand control signaling.

In embodiments, sensor electronics module 12 is configured to search forand/or attempt wireless communication with a list of display devices110, 120, 130, 140 in a predetermined and/or programmable order (e.g.,grading and/or escalating), for example, wherein a failed attempt atcommunication with and/or alarming with a first one of display devices110, 120, 130, 140 triggers an attempt at communication with and/oralarming with a second one of display devices 110, 120, 130, 140, and soon. In example embodiments, sensor electronics module 12 is configuredto search for and attempt to alarm a host or care provider sequentiallyusing a list of display devices 110, 120, 130, 140, such as: (1) adefault display device (e.g., one of display devices 110, 120, 130, 140)or a custom analyte monitoring device (e.g., display device 110); (2) amobile phone (e.g., display device 120) via auditory, haptic, and/orvisual methods, such as text message to the host and/or care provider,voice message to the host and/or care provider, and/or 911; (3) a tablet(e.g., display device 130); (4) a smart watch (e.g., display device140). Of course, other types of display devices are encompassed and/ordescribed herein, and alarms may additionally or alternatively be sentto partner devices 136 and/or server system 334.

Depending on the embodiment, one or more display devices 110, 120, 130,140 that receive data packages from sensor electronics module 12 can beadapted to be “dummy displays,” wherein they display the displayablesensor information received from sensor electronics module 12 withoutadditional processing (e.g., prospective algorithmic processing that maybe necessary for real-time display of sensor information). Inembodiments, the displayable sensor information comprises transformedsensor data that does not require processing by the display device priorto display of the displayable sensor information. Some display devices110, 120, 130, 140 may include software including display instructions(software programming that includes instructions configured to displaythe displayable sensor information and optionally query sensorelectronics module 12 to obtain the displayable sensor information)configured to enable display of the displayable sensor informationthereon. In embodiments, display device 110, 120, 130, 140 is programmedwith the display instructions at the manufacturer and can includesecurity and/or authentication to avoid plagiarism of display device110, 120, 130, 140 and/or unauthorized access thereof. In embodiments,display device 110, 120, 130, 140 is configured to display thedisplayable sensor information via a downloadable program (for example,a downloadable Java Script via the Internet), such that any displaydevice 110, 120, 130, 140 that supports downloading of a program (forexample, any display device 110, 120, 130, 140, such as, e.g., mobilephones, tablets, PDAs, PCs, and the like, that supports Java applets)therefore can be configured to display displayable sensor information.

In embodiments, certain display devices 110, 120, 130, 140 may be indirect wireless communication with sensor electronics module 12, butintermediate network hardware, firmware, and/or software can be includedwithin the direct wireless communication path. In embodiments, arepeater (e.g., a Bluetooth repeater) can be used to re-transmit thetransmitted displayable sensor information to a location farther awaythan the immediate range of the telemetry module of sensor electronicsmodule 12, wherein the repeater enables direct wireless communicationwhen substantive processing of the displayable sensor information doesnot occur. In embodiments, a receiver/transmitter (e.g., Bluetoothreceiver/transmitter) can be used to re-transmit the transmitteddisplayable sensor information, possibly in a different format, such asin a text message onto a TV screen, wherein the receiver/transmitterenables direct wireless communication when substantive processing of thesensor information does not occur. In embodiments, sensor electronicsmodule 12 directly wirelessly transmits displayable sensor informationto one or a plurality of display devices 110, 120, 130, 140, such thatthe displayable sensor information transmitted from sensor electronicsmodule 12 is received by one or more of display devices 110, 120, 130,140 without intermediate processing of the displayable sensorinformation.

In embodiments, one or more display devices 110, 120, 130, 140 includebuilt-in authentication mechanisms, wherein authentication may berequired for communication between sensor electronics module 12 anddisplay device 110, 120, 130, 140. In embodiments, to authenticate thedata communication between sensor electronics module 12 and displaydevices 110, 120, 130, 140, a challenge-response protocol, such as keyauthentication is provided, where the challenge is a request for the keyor a hash or other value based on or derived from the key, and the validresponse is the correct key or a hash or other value based on or derivedfrom the key, such that pairing of sensor electronics module 12 withdisplay devices 110, 120, 130, 140 can be accomplished by the userand/or manufacturer via the key. This may be referred to in some casesas two-way authentication. The key may be a software or hardware levelkey. Additionally, the key may be a password (e.g., randomly generatedor set by a user or other entity), and/or may be derived from uniquelyidentifying features (e.g., finger print, facial, or retinalinformation) or information, etc.

In embodiments, one or more display devices 110, 120, 130, 140 areconfigured to query sensor electronics module 12 for displayable sensorinformation, wherein display device 110, 120, 130, 140 acts as a masterdevice requesting sensor information from sensor electronics module 12(e.g., a slave device) on-demand, for example, in response to a query.Although in some cases display device 110, 120, 130, 140 acts as amaster and sensor electronics module 12 acts as a slave, in other cases,these roles may be reversed. For example, the roles can reversedepending on the nature of the communication and so on.

In embodiments, sensor electronics module 12 is configured for periodic,systematic, and/or regular transmission of sensor information to one ormore display devices 110, 120, 130, 140 (for example, every 1, 2, 5, or10 minutes or more or less). In embodiments, sensor electronics module12 is configured to transmit data packages associated with a triggeredalert (e.g., triggered by one or more alert conditions). However, anycombination of the above described statuses of data transmission can beimplemented with any combination of paired sensor electronics module 12and display device(s) 110, 120, 130, 140. For example, one or moredisplay devices 110, 120, 130, 140 can be configured for querying sensorelectronics module 12 (directly or indirectly) and for receiving alarminformation triggered by one or more alarm conditions being met.Additionally, sensor electronics module 12 can be configured forperiodic transmission of sensor information to one or more displaydevices 110, 120, 130, 140 (the same or different display devices asdescribed in the previous example), whereby a system can include displaydevices 110, 120, 130, 140 that function differently with regard to howsensor information is obtained.

In embodiments, a display device 110, 120, 130, 140 is configured toquery the data storage memory in sensor electronics module 12 (e.g.,storage 515 with reference to FIG. 3C) for certain types of datacontent, including direct queries into a database in a memory or storageof sensor electronics module 12 and/or requests for configured orconfigurable packages of data content therefrom; namely, the data storedin sensor electronics module 12 can be configurable, queryable,predetermined, and/or pre-packaged, based on characteristics and/orrequests of display device 110, 120, 130, 140 with which sensorelectronics module 12 is communicating. In additional or alternativeembodiments, sensor electronics module 12 generates the displayablesensor information based on information known to sensor electronicsmodule 12 regarding which display device 110, 120, 130, 140 is toreceive a particular transmission. Additionally, some display devices110, 120, 130, 140 may be capable of obtaining calibration informationand wirelessly transmitting the calibration information to sensorelectronics module 12, such as through manual entry of the calibrationinformation, automatic delivery of the calibration information, and/oran integral reference analyte monitor incorporated into display device110, 120, 130, 140. U.S. Patent Publication Nos. 2006/0222566,2007/0203966, 2007/0208245, and 2005/0154271, all of which areincorporated herein by reference in their entireties, describe systemsand methods for providing an integral reference analyte monitorincorporated into a display device (e.g., display device 110, 120, 130,140) and/or other calibration methods that can be implemented withembodiments disclosed herein. In embodiments, some display devices 110,120, 130, 140 are capable of transmitting the calibration information topartner device(s) 136.

In general, a plurality of display devices (e.g., a custom analytemonitoring device, which may also be referred to in some instancesanalyte display device 110, mobile phone 120, tablet 130, smart watch140, a reference analyte monitor, a drug delivery or medicament device,a medical device, and a personal computer etc.) may be configured towirelessly communicate with sensor electronics module 12. The pluralityof display devices 110, 120, 130, 140 may be configured to display atleast some of the displayable sensor information wirelessly communicatedfrom sensor electronics module 12. The displayable sensor informationmay include sensor data, such as raw data and/or transformed sensordata, such as analyte concentration values, rate of change information,trend information, alert information, sensor diagnostic informationand/or calibration information, for example. In embodiments, displaydevice 110, 120, 130, 140 may receive analyte data from analyte sensorsystem 8 indirectly via another device (e.g., partner device 136 and/orserver system 134). In embodiments, display device 110, 120, 130, 140may send commands or other control/configuration signaling to analytesensor system 8 indirectly via another device (e.g., partner device 136and/or server system 134). Alerts, alarms, and/or notifications relatedto the analyte data may also be provided (whether visually, audibly,and/or haptically) using display devices 110, 120, 130, 140. Additionaltypes of information that may be received at display devices 110, 120,130, 140 may include information related to battery life or powerconsumption, other diagnostics, timing, and so forth.

In some instances, display device 110, 120, 130, 140 that hassuccessfully communicated with analyte sensor system 8 and successfullycompleted an authentication process can be considered as an approveddisplay device 110, 120, 130, 140. In some instances, display device110, 120, 130, 140 may be configured in a display only state, wheredisplay device 110, 120, 130, 140 can access analyte data in a read anddisplay manner. In this state, display device 110, 120, 130, 140typically does not send to analyte sensor system 8 commands related tocontinuous glucose monitoring (CGM). Nevertheless, other commands may besent in this state. Example CGM commands include commands to start,stop, or calibrate a CGM sensor session in which the analyte sensorsystem 8 is used to generate analyte data. Examples of non-CGM commandsinclude commands that do not affect the calculation of CGM data. Suchnon-CGM commands include, for example, a command to change advertisingparameters, to modify whitelist criteria, and to add an additionaldisplay device 110, 120, 130, 140 in read only mode. Examples of displaydevices 110, 120, 130, 140 that may typically operate in the displayonly state include a small device such as a key fob, where the key fobdisplays analyte data and alerts/alarms/notifications related thereto.In some circumstances, however, any display device 110, 120, 130, 140may operate in the display only state, as will be described herein.

In some instances, display device 110, 120, 130, 140 may be configuredin a display and control state, where in addition to accessing analytedata in a read and display manner, display device 110, 120, 130, 140 cansend commands related to CGM, as well as other commands. In this state,other types of data may be readable/displayable, and as mentioned,display device 110, 120, 130, 140 can send various types of commands toanalyte sensor system 12 in addition to CGM commands.

FIG. 4 depicts example aspects of the present disclosure that may beused in connection with implementing display device 310 that isconnectable to, for example, analyte sensor system 308 and/or partnerdevice 315. It is to be appreciated that many details of the processing,gathering, and exchanging data by analyte sensor system 308, partnerdevices 315, and/or display device 310 etc. are provided elsewhereherein. It will be appreciated upon studying the present disclosure thatdisplay device 310 may contain several like components that may have aredescribed with respect to FIG. 3C and/or FIG. 5B, at least forembodiments. The details and uses of such like components may thereforebe understood vis-à-vis display device 310 even if not expresslydescribed here with reference to FIG. 4.

As illustrated in FIG. 4, display device 310 may include a number ofcomponents for communicatively coupling with analyte sensor system 308and/or partner device 315 via communication media 305. Display device310 may be used for alerting a user and/or for providing sensorinformation or analyte data, control signaling, and/or other information(e.g., relating to partner device 315 and/or the delivery ofmedicaments) to the user and/or analyte sensor system 308, anotherdisplay device 310, and/or partner device 315. Display device 310 mayinclude one or more of connectivity interface 405 (which in turnincludes transceiver 320), storage 415 (which in turn stores analytesensor application 425 a, partner device application 425 b, and/oradditional applications), processor/microprocessor 430 for processingand managing sensor and/or other data, user interface 435 (e.g., aman-machine interface, audio or visual interface (display, LEDs,speakers, microphone, and the like), haptic feedback, etc.) that may beused to provide/present information to a user and/or receive input fromthe user, and real time clock (RTC) 445. A bus (not shown here) may beused to interconnect the various elements of display device 310 andtransfer data between these elements.

Transceiver 410 may be used for receiving sensor and/or other data andfor sending/receiving requests, instructions, other signaling, and/ordata to/from analyte sensor system 308, partner device 315, and/orserver system 334. Transceiver 410 may employ a communication protocolfor sending and receiving the aforementioned information. Inembodiments, when a standardized communication protocol is used forcommunications with (to/from) display device 310, commercially availabletransceiver circuits may be utilized in transceiver 410 that incorporateprocessing circuitry to handle low level data communication functionssuch as the management of data encoding, transmission frequencies,handshake protocols, and the like. In these embodiments, processor 430may but does not necessarily need to manage these activities, but rathercan provide desired data values for transmission, and manage high levelfunctions such as power up or down, setting a rate at which messages aretransmitted, and the like. Instructions and data values for performingthese high level functions can be stored in storage 415 and provided tothe transceiver circuits via a data bus and transfer protocolestablished by the manufacturer of the transceiver 410.

Connectivity interface 405 can be used to interface display device 310to communication media 305, such that display device 310 may becommunicatively coupled (directly or indirectly) to analyte sensorsystem 308, another display device 310, and/or partner device 315 viacommunication media 305 (for example with reference to FIG. 2A).Transceiver 410 of connectivity interface 405 may include multipletransceiver modules operable on different wireless standards and/orfrequency bands. Transceiver 410 may be used to send/receive analyte ormedicament delivery data and/or associated commands and messages to/fromanalyte sensor system 308, as well as to wirelessly communicate withpartner device 315. Additionally, connectivity interface 405 may in somecases include additional components for controlling radio and/or wiredconnections, such as baseband and/or Ethernet modems, audio/videocodecs, and so on.

Storage 415 may be used for storing an operating system for displaydevice 310 and/or a custom (e.g., proprietary) application designed forwireless data communication between a remote transceiver and displaydevice 310. Storage 415 may be a single memory device or multiple memorydevices and may be a volatile or non-volatile memory for storing dataand/or instructions for software programs and applications. Theinstructions may be executed by processor/microprocessor 430, forexample to control and manage transceiver 410, user interface 435,applications 425 a, 425 b, and/or other components of display device310. Storage 415 may include volatile memory (e.g., RAM) and/ornon-volatile memory (e.g., flash storage), may include any of EPROM,EEPROM, cache, and/or may include some combination/variation thereof. Invarious embodiments, storage 415 may store user input data and/or otherdata collected by display device 310 (e.g., input from other usersgathered via analyte sensor application 425 a and/or partner deviceapplication 425 b, and/or information related to partner device 315,including medicament delivery data and associated information). Storage415 may also be used to store volumes of analyte-related data receivedfrom analyte sensor system 308 and/or volumes of medicament-related datareceived from partner device 315, for later retrieval and use, e.g., fordetermining trends and/or triggering alerts. Additionally, storage 415may store analyte sensor application 425 a and/or partner deviceapplication 425 b that, when executed using processor 430, for example,receive input (e.g., by a conventional hard/soft key or a touch screen,voice detection, or other input mechanism or user interface 435), andallows a user to interact with the analyte-related data and relatedcontent, and/or medicament-related data and related content, and/orother information (e.g., related to system configurations), for examplevia a GUI.

In embodiments, a user may interact with analyte sensor application 425a and/or partner device application 425 b via a GUI, which may beprovided by a display of user interface 435 of display device 310. TheGUI of display device 310 may perform such functions as accepting userinput and displaying menus as well as information derived from analytedata or medicament data, for example. The GUI may be provided by variousoperating systems known in the art, such as, for example, iOS, Android,Windows Mobile, Windows, Mac OS, Chrome OS, Linux, Unix, a gamingplatform OS (e.g., Xbox, PlayStation, Wii), etc. By way of example, thedisplay may be a touchscreen display that accepts various hand gesturesas inputs.

In embodiments, application 425 a may process and/or presentanalyte-related data received by display device 310, according tovarious operations described herein, and present such data via thedisplay of user interface 435. Additionally, application 425 a may beused to obtain, access, display, control, and/or interface with analytedata and related messaging and processes associated with analyte sensorsystem 308, as is described in further detail herein.

Application 425 a may be downloaded, installed, and initiallyconfigured/setup on display device 310. For example, display device 310may obtain application 425 a from server system 334, or from anothersource accessed via communication media 305, such as an applicationstore or the like. Following installation and setup, application 425 amay be used to access and/or interface with analyte data (e.g., whetherstored on server system 334, locally from storage 415, or from analytesensor system 308). By way of illustration, application 425 a maypresent a menu that includes various controls or commands that may beexecuted in connection with the operating of analyte sensor system 308and one or more display devices 310. Application 425 a may also be usedto interface with or control other display devices 310, and/or withpartner device 315, for example, to deliver or make available theretoanalyte-related data, including for example by receiving/sending analytedata directly to the other display device 310 and/or partner device 315,and/or by sending an instruction for analyte sensor system 308 and theother display device 310 and/or partner device 315 to be connected,etc., as will be described herein. Additionally, application 425 a insome implementations may interact with one or more additionalapplications supported by display device 310, for example to retrieve orsupply relevant data. Such applications may include, by way of example,fitness/lifestyle monitoring applications, social media applications,and so on. Such applications may also include applications associatedwith partner device 315, including partner device application 425 b,which will be described in detail below.

Analyte sensor application 425 a may involve various code/functionalmodules, such as, for example, a display module, a menu module, a listmodule, and so on as will become clear in light of the description ofvarious functionalities herein (e.g., in connection with disclosedmethods). These modules may be implemented separately or in combination.Each module may include (non-transitory) computer-readable media andhave computer-executable code stored thereon, such that the code may beoperatively coupled to and/or executed by processor 430 (which, e.g.,may include a circuitry for such execution) to perform specificfunctions (e.g., as described herein with regard to various operationsand flow charts etc.) with respect to interfacing with analyte-relateddata and performing tasks related thereto, as well as to interface withother applications/devices.

As will be further described below, a display module may present (e.g.,via a display of user interface 435) various screens to a user, with thescreens containing graphical representations of information provided byapplication 425 a. In further embodiments, application 425 a may be usedto display to the user an environment for viewing and interacting withvarious display devices 310 that may be connectable to analyte sensorsystem 308, as well as with analyte sensor system 308 itself, and/orwith partner device 315. Sensor application 425 a may include a nativeapplication modified with a software design kit (e.g., depending on theoperating system) in order to carry out the functionalities/featuresdescribed herein.

With further reference to FIG. 4, partner device application 425 b mayalso be included in storage 415 and, when executed using processor 430for example, application 425 b may be used to receive input (e.g., by aconventional hard/soft key or a touch screen, voice detection, or otherinput mechanism or user interface 435), and can allow a user to interactwith the medicament-related data and related content, for example via aGUI of user interface 435. Application 425 b may process and/or presentmedicament-related and other partner device or system data received byor sent from display device 310, according to various operationsdescribed herein, and present such data via the display of userinterface 435. Additionally, application 425 b may be used to obtain,access, display, control, and/or interface with medicament, analyte,and/or other data and related messaging and processes associated withpartner device 315, display device 310, and/or server system 334, as isdescribed in further detail herein.

In embodiments, application 425 b may be downloaded, installed, andinitially configured/setup on display device 310. For example, displaydevice 310 may obtain application 425 b from server system 334, whereapplication 425 b may be provided by a manufacturer of partner device315 in some cases, or from another source accessed via communicationmedia 305, such as an application store or the like. Followinginstallation and setup, application 425 b may be used to access and/orinterface with partner device 315, including medicament-related data(e.g., whether stored on server system 334, locally from storage 415, orfrom partner device 315 and/or analyte sensor system 308). By way ofillustration, application 425 b may cause user interface 435 to presenta menu that includes various controls or commands that may be executedin connection with the operating of partner device 315, analyte sensorsystem 308, and/or one or more display devices 310.

Application 425 b may also be used to interface with or control otherdisplay devices 310, and/or with partner device 315 vis-à-vis theoperation of partner device 315 in the systems/ecosystems describedherein, for example, to receive/deliver or make availablemedicament-related data, including for example by receivingmedicament-related data from partner device 315 and/or analyte sensorsystem 308, and/or by sending an instruction for analyte sensor system308 and/or partner device 315 to be connected or operate in a particularmanner, etc., as will be described herein. Additionally, application 425b in some implementations may interact with one or more additionalapplications supported by display device 310, for example to retrieve orsupply relevant data. Such applications may include, by way of example,fitness/lifestyle monitoring applications, social media applications,and so on. Such applications may also include applications associatedwith analyte sensor system 308 and/or display device 310, includinganalyte sensor application 425 a. By way of example, communicationbetween analyte sensor application 425 a and partner device application425 b may facilitate the sharing and coordination of alert informationoriginating from analyte sensor system 308 and/or partner device 315.

Partner device application 425 b may include various code/functionalmodules, such as, for example, a display module, a menu module, a listmodule, and so on as will become clear in light of the description ofvarious functionalities herein (e.g., in connection with disclosedmethods). These modules may be implemented separately or in combination.Each module may include (non-transitory) computer-readable media andhave computer-executable code stored thereon, such that the code may beoperatively coupled to and/or executed by processor 430 to performspecific functions with respect to interfacing with partner device 315,display device 310, server system 334, and/or medicament-related oranalyte-related data or other information, and/or performing tasksrelated thereto, as well as to interface with otherapplications/devices.

As will be further described below, a display module may present (e.g.,via a display of user interface 435) various screens to a user, with thescreens containing graphical representations of information provided byapplication 425 b. In further embodiments, application 425 b may be usedto display to the user an environment for viewing and interacting withvarious partner devices 315 that may be connectable to analyte sensorsystem 308 and/or display device 310. Sensor application 425 b mayinclude a native application modified with a software design kit (e.g.,depending on the operating system) in order to carry out thefunctionalities/features described herein. Such software design kits maybe provided by the manufacturer of partner device 315, or by otherentities.

As illustrated in FIG. 4, storage 415 of display device 310 may alsoinclude configuration parameters 420. Configuration parameters 420, inembodiments, govern aspects of wireless communication between/amongdisplay device 310, analyte sensor system 308, and/or partner device315. Configuration parameters 420 will be described in further detailbelow, for example with reference to FIGS. 5B, 8, 9A-9S, 10A, and 10B,etc. System requirements 450 may also be stored in storage 415. Systemrequirements 450 may pertain to partner device 315, and will bedescribed in further detail with reference to FIGS. 5B, 8, 9A-9S, 10A,and 10B, by way of example.

Referring again to FIG. 4, as discussed above, display device 310 alsoincludes processor/microcontroller 430. Processor 430 may includeprocessor sub-modules, including, by way of example, an applicationsprocessor that interfaces with and/or controls other elements of displaydevice 310 (e.g., connectivity interface 405, applications 425 a, 425 b,user interface 435 and components thereof, RTC 445, etc.). Processor 430may include a controller and/or microcontroller that provides variouscontrols (e.g., interfaces with virtual buttons/inputs and switchesetc.) related to device management, such as, for example, lists ofavailable or previously paired devices, information related tomeasurement values, including analytes and medicaments, informationrelated to network conditions (e.g., link quality and the like),information related to the timing, type, and/or structure of messagingexchanged among analyte sensor system 308, display device 310, and/orpartner device 315, information related to diagnostics of varioussystems, information related to power management of analyte sensorsystem 308, display device 310, and/or partner device 315, and so on.Additionally, the controller may include various controls related to thegathering of user input, such as, for example, a user's finger print(e.g., to authorize the user's access to data or to be used forauthorization/encryption of data, including analyte data) or otheridentifying information, as well as analyte data and/or medicamentdelivery data and/or related information.

Processor 430 may include circuitry such as logic circuits, memory, abattery and power and related management circuitry, and other circuitrydrivers for periphery components and audio/video and other components ofdisplay device 310. Display device 310 may include other peripheralcomponents not shown in detail in FIG. 4, and processor 430 may beadapted to drive such peripheral components. Processor 430 and anysub-processors thereof may include logic circuits for receiving,processing, and/or storing data received and/or input to display device310, and data to be transmitted or delivered by display device 310.Processor 430 may be coupled (e.g., by a bus) to user interface 435 aswell as connectivity interface 405 and storage 415 (includingapplications 425 a, 425 b). Hence, processor 430 may receive and processelectrical signals generated by these respective elements and thusperform various functions. By way of example, processor 430 may accessstored content from storage 415 at the direction of application 425 aand/or 425 b, and process the stored content for display and/or outputby a display or other mechanism of user interface 435. Additionally,processor 430 may process the stored content for transmission viaconnectivity interface 405 and communication media 305 to other displaydevices 310, analyte sensor system 308, server system 334, and/orpartner device 315.

In embodiments, processor 430 may further obtain, detect, calculate,and/or store data input by a user via user interface 435, or datareceived from analyte sensor system 308 (e.g., analyte sensor data andrelated messaging) and/or partner device 315 (e.g., medicament deliverydata and related data/messaging), over a period of time. Processor 430may use this input to gauge the user's physical and/or mental responseto the analyte, medicament, or data, as well as other factors (e.g.,time of day, location, etc.). In various embodiments, the user'sresponse or other factors may indicate preferences with respect to theuse of certain display devices 310 and/or partner devices 315 undercertain conditions, preferred dosages under certain conditions, and/orthe use of certain connection/transmission schemes under variousconditions, as will be described in further detail herein.

E. Partner Devices

Referring again to FIG. 1, in embodiments of the present disclosure, theabove-described sensor electronics module 12 is configured to search forand/or attempt wireless communication with partner device 136. By way ofan overview and an example, a typical partner device 136 can communicatewirelessly with analyte sensor system 8, including for authentication ofpartner device 136 and/or analyte sensor system 8, as well as theexchange of analyte data, medicament data, other data, and/or controlsignaling. Partner devices 136 may include a passive device in exampleembodiments of the disclosure.

FIG. 5A illustrates one example of partner device 136, which as shownmay be an insulin pump for administering insulin to a user. For avariety of reasons, it may be desirable for such an insulin pump toreceive and track glucose values transmitted from analyte sensor system8 (with reference to FIG. 1 for example). One reason for this is toprovide the insulin pump a capability to suspend/activate insulinadministration based on a glucose value being below/above a thresholdvalue. One example solution that allows a passive device (e.g., partnerdevice 136) to receive analyte data (e.g., glucose values) without beingbonded to analyte sensor system 8, is to include the analyte data in theadvertisement messages transmitted from analyte sensor system 8 (asdiscussed by way of example with reference to FIG. 7C). The dataincluded in the advertisement messages can be encoded so that only adevice that has the identification information associated with analytesensor system 8 can decode the analyte data.

Partner device 136 may include input/output portion 136 a, in which, forexample, glucose and other values may be displayed and input may bereceived via buttons, wireless connection, or other mechanisms,including a variety of user interface features. Partner device 136 mayalso include attachment portion 136 b that interfaces with the user to,for example, administrate insulin responsive to the input received atinput/output portion 136 a. In some cases, attachment portion 136 b mayprovide sensory alerts or other notifications to the user based on, forexample, the input received and/or values calculated at input/outputportion 136 a. It should be understood that insulin pumps can beimplemented in many additional or alternative configurations of partnerdevice 136.

More generally, partner devices 136 may include medical and otherdevices configured to use analyte data received from analyte sensorsystem 8 for patient treatment and/or guidance. Partner devices 136 maygenerally include medicament delivery devices, where the delivery ofmedicaments to patients is conditioned on, among other factors,characteristics of analyte data received from analyte sensor system 8.One example of partner device 136 is an insulin pump. Another example ofpartner device 136 is an insulin pen. Partner device 136 may be adaptedto run a medicament delivery application using code or instructionsstored in a memory or storage of partner device 136, as will bedescribed in more detail herein (e.g., with reference to FIG. 5B).

Partner device 136, such as for example an insulin pump that deliversmedicaments to a patient automatically, may impose requirements on thequality and/or nature of the wireless connection/link over which partnerdevice 136 receives analyte data used to make decisions regarding themedicament delivery, as well as on the configuration of the ecosystem inwhich partner device 136 is being used. Additional types of partnerdevices 136 may likewise impose similar or other requirements. Forexample, some partner devices 136 may require a more dedicated, robustconnection so that, e.g., the user or patient relying on the pump forinsulin delivery does not miss an insulin dose. In such examples, theconnection via which the insulin pump receives analyte data should berelatively secure and reliable, and interference from other devices(e.g., display devices 110, 120, 130, 140) should be reduced. As anotherexample, partner devices 136 may have certain constraints on batterylife, accuracy with respect to the calculation of CGM data, and soforth. Partner devices 136 may be able to send CGM commands as well asother types of commands to analyte sensor system 8, and also to controlthe mode of operation of the analyte sensor system 8 according to systemrequirements 650 of partner device 136, as will be described herein (forexample, referencing FIG. 5B).

In example implementations where partner device 136 is an insulin pump,the insulin pump receiving analyte data from analyte sensor system 8 andengaging in automatic insulin delivery may for example seek to preventother display devices 110, 120, 130, 140 from sending CGM controlcommands to analyte sensor system 8. Such CGM control commands couldaffect the algorithm used to calculate CGM data, and as a result affectthe amount of insulin delivered by the insulin pump, which may not bedesirable/expected. In order to maintain control over the amount ofinsulin delivered, it may be desirable for the insulin pump to be ableto prevent display devices 110, 120, 130, 140 from sending such CGMcontrol commands. This may be done using various techniques describedherein.

Other types of partner devices 136, for example, insulin pens, smartfridges, smart mirrors, vehicles, and any other connected device, mayimpose different or similar requirements, and/or may have more relaxedrequirements for wireless communication and other performance aspects.Injection devices such as an insulin pen may receive analyte data fromanalyte sensor system 8 and use the analyte data to provide aninstruction or guidance (e.g., whether graphical, audible, haptic, etc.)to a user that the user should (or should not) administer medicaments(e.g., inject insulin), and may also include a dosage or injectiontiming suggestion. That is, unlike the insulin pump implementations ofpartner devices 136, an insulin pen may rely upon useraction/intervention. A smart fridge implementation of partner device 136may connect to analyte sensor system 8, monitor analyte data as well asa user's food/drink consumption, and provide feedback to the userrelating to the user's expected or resulting blood glucose levels asrelated to the food/drink consumption. A smart mirror implementation ofpartner device 136 may connect to analyte sensor system 8 and/or displaydevice 110, 120, 130, 140 and provide the user with a head-up display ofanalyte information and/or other guidance cues for diabetes managementor other kinds of healthcare suggestions.

As will be appreciated, just as many different types of partner devices136 are contemplated, there is also a large number of manufacturers thatmay provide partner devices 136 for operation with analyte sensor system8 and/or display devices 110, 120, 130, 140. Across the spectrum ofdevice types and manufacturers, etc., there exists a need forflexibility and adaptability in the system so that interoperability,predictability, and expanded use can be maintained and fostered, and sothat the interaction and performance of the various devices can becontrolled and/or optimized.

Turning now to FIG. 5B, a more detailed example functional block diagramof partner device 315 is provided. It will be appreciated upon studyingthe present disclosure that with respect to partner device 315, severallike components are described with respect to FIGS. 4 and 5 and displaydevice 310 and analyte sensor system 308, at least for some embodiments,and the details and uses of the applicability of such like componentswill be understood vis-à-vis partner device 315 even if not expresslydescribed with reference to FIG. 5B.

As shown in FIG. 5B, embodiments of partner device 315 may includemedicament delivery mechanism 640 that may be used to delivermedicaments (e.g., insulin) to a user, including based on analyte datagenerated using analyte sensor system 308 and received at partner device315 via communication media 305. For example, where partner device 315is an insulin pump, medicament delivery mechanism 640 may in embodimentsinclude an infusion set that can deliver insulin from a cannula or othertype of reservoir within or external to partner device 315. Or, forexample, where partner device 315 is an insulin pen, medicament deliverymechanism 640 may include a needle that may be used to inject insulininto the user.

Partner device 315 may also include processor/microcontroller 630 thatmay be coupled to a radio unit or transceiver 610 for sending/receivingsensor data and requests and commands and other signaling to/from anexternal device, such as display device 310 and/or analyte sensor system308 and/or another partner device 315. Transceiver 610 may be part ofconnectivity interface 605 within partner device 315 and may also beused to send medicament-related information, including dosage, bolusinformation, alerts/alarms/notifications, etc. to analyte sensor system308, display device 310, other partner devices 315, and/or server system334 (referencing FIG. 2A).

Partner device 315 may further include storage 615 and real time clock(RTC) 645, for storing and tracking medicament delivery data, sensordata, and/or other information (e.g., command/control signaling, linkcharacteristics, user input, etc.). Storage 615 may store, among otherinformation/items, medicament delivery application 625 and/or otherapplications, and/or system requirements 650. System requirements 650 ofpartner device 315 may be imposed to address safety, regulatory, userexperience, power consumption, reliability, and/or accuracy requirementson the operation and/or performance of partner device 315, as well as insome cases other requirements that apply to the ecosystem in whichpartner device 315 is used.

Medicament delivery application 625 may process and/or present analyte,medicament, and/or other data received by or sent from partner device315 (e.g., received from analyte sensor system 308, display device 310,another partner device 315, and/or server system 334), according tovarious operations described herein, and may present aspects of somesuch data via user interface 635. Additionally, application 625 may beused in connection with user interface 635 to obtain, access, display,control, and/or interface with medicament, analyte, and/or other dataand related messaging and processes associated with partner device 315,display device 310, analyte sensor system 308, and/or server system 334.For example, user interface 635 may allow a user to enter user or otherinformation into partner device 315 to assist in administeringmedicaments to the user, to authenticate the user (e.g., by fingerprint,facial, voice, or security code etc.), and/or to enter user preferencesor plans for operation of partner device 315 (e.g., planned use ornon-use, mode control, etc.), and/or analyte sensor system 308 (e.g.,sensor replacement, expected operation time, etc.), and/or displaydevice 310 (e.g., permissions for accessing data from partner device315). It will also be appreciated that application 625 may run onpartner device 315 but may not be user-visible thereon. For example,while application 625 may be used to execute instructions forcontrolling the operation of partner device 315, a user's interfacingwith application 625 may be done via display device 310 (or in somecases not at all).

Application 625 may be downloaded, installed, and initiallyconfigured/setup on partner device 315. For example, partner device 315may obtain application 625 from server system 334, where application 625may be provided by a manufacturer of partner device 315 in some cases,or from another source accessed via communication media 305, such as anapplication store or the like. Following installation and setup,application 625 may be used to access and/or interface with partnerdevice 315, including medicament-related data (e.g., whether stored onserver system 334, locally from storage 615, or from display device 310and/or analyte sensor system 308). By way of illustration, application625 may be used to present a menu (whether on display device 310,analyte sensor system 308, and/or partner device 315) that includesvarious controls or commands that may be executed in connection with theoperating of partner device 315, analyte sensor system 308, and/or oneor more display devices 310.

Application 625 may also be used to interface with or control displaydevices 310, and/or with other partner device 315 vis-à-vis theoperation of partner device 315 in the systems/ecosystems describedherein, for example, to receive/deliver or make available medicament ordata, including for example by receiving medicament-related oranalyte-relate data from partner device 315, display device 310, and/oranalyte sensor system 308, and/or by sending an instruction for analytesensor system 308, display device 310, and/or partner device 315 to beconnected in a particular manner, mode, etc., as will be describedherein (e.g., with reference to FIGS. 8 and 9A-9S). Additionally,application 625 in some implementations may interact with one or moreadditional applications supported by display device 310, for example toretrieve or supply relevant data. Such applications may include, by wayof example, fitness/lifestyle monitoring applications, social mediaapplications, and so on. Such applications may also include applicationsassociated with analyte sensor system 308 and/or display device 310,including analyte sensor application 425 a and partner deviceapplication 425 b.

Medicament delivery application 625 may include various code/functionalmodules, such as, for example, a medicament delivery module, anauthentication module, a system configuration module, and so on as willbecome clear in light of the description of various functionalitiesherein (e.g., in connection with disclosed methods). These modules maybe implemented separately and/or in combination. Each module may include(non-transitory) computer-readable media and have computer-executablecode stored thereon, such that the code may be operatively coupled toand/or executed by processor 630 to perform specific functions withrespect to interfacing with partner device 315 and/or medicament-relateddata, and/or performing tasks related thereto, as well as to interfacewith other applications/devices (e.g., display device 310, analytesensor system 308, etc.).

As will be further described below, a display module of display device310 or of partner device 615 may present (e.g., via a display of userinterface 435, with reference to FIG. 4, and/or of user interface 635,with reference to FIG. 5B) various screens to a user, with the screenscontaining graphical representations of information provided byapplication 625 (e.g., insulin dosage information). In furtherembodiments, application 625 may be used to display to the user ofdisplay device 310 an environment for viewing and interacting withpartner device 315. In embodiments, partner device 315 may include adisplay as part of user interface 635, in which case application 625 mayprovide information for display directly on partner device 315 (asopposed to using display device 310). Medicament delivery application625 may include a native application modified with a software design kit(e.g., depending on the operating system) in order to carry out thefunctionalities/features described herein. Such software design kits maybe provided by the manufacturer of partner device 315, or by otherentities.

As shown in FIG. 5B, partner device 315 optionally includes partnerdevice controller 645. Partner device controller 645 may be used inconjunction with partner device 315 to add capabilities thereto. Forexample, in embodiments, partner device 315 may not be equipped withradio connectivity hardware/software. In such embodiments, partnerdevice controller 645 may be a “bolt-on” piece of hardware that cancouple to partner device 315 via connectivity interface 605 and augmentthe operational capability of partner device 315, for example byproviding or adding a transceiver, memory, and/or processingcapabilities (including, e.g., software code/instructions supporting thesame). Thus, in example implementations, partner device controller 645may include a BLE or other radio for communicatively coupling partnerdevice 315 to analyte sensor system 308 and/or display device 310. Inembodiments, medicament delivery application 625 may reside at leastpartially on partner device controller 645. In embodiments, userinterface 635 may reside at least partially on partner device controller645. For example, if partner device lacks a user interface such as adisplay, partner device controller may be used to add displaycapabilities to partner device 315.

It should be noted at this juncture that like-named elements as betweendisplay device 310, analyte sensor system 308, and/or partner device 315as described in FIGS. 3C, 4, 5A, 5B, may in some cases include similarfeatures, structures, and/or capabilities. Therefore, with respect tosuch elements, the description of such elements with reference to anyone of display device 310, analyte sensor system 308, and partner device315 above may in some cases be applied to the corresponding or analogouselement within any one of display device 310, analyte sensor system 308,and partner device 315.

F. Advertising Timing and Structure

An additional aspect of the present disclosure involves the order andmanner in which various devices (e.g., display devices 310 and partnerdevices 315) connect to analyte sensor system 308, which can depend uponthe order, timing, structure, and manner of advertisement messagestransmitted to such display devices 310 and/or partner devices 315. Onepotential scheme for the ordering of connection for various devices maybe described as follows.

In embodiments, analyte sensor system 308 advertises to and establishesconnections with display devices 310 and/or partner devices 315 that areavailable for connection (e.g., that are in-range and/or otherwiseavailable). This may be done, for example, by transmitting advertisementmessages. By way of example, reference is made to operation 1005 a shownin FIG. 7A. On the display device 310/partner device 315 side, displaydevices 310 and/or partner devices 315 seeking a connection with analytesensor system 308 may in example embodiments scan for analyte sensorsystem 308 or another like sensor system to enter into a connectiontherewith. This generally entails receiving and processing advertisementmessages that are being broadcast by analyte sensor system 308 etc., inorder to determine whether any such messages are being transmitted by acompatible/desirable analyte sensor system 308.

Display device 310 and/or partner device 315 may then respond to theadvertisement message by sending a connection request back to analytesensor system 308. By way of example, reference is made to operation1005 b shown in FIG. 7A. Upon receiving the connection request, analytesensor system 308 may accept, deny, or simply ignore the request. Inexample implementations, analyte sensor system 308 serves only onedisplay device 310 or partner device 315 connection at a time.Therefore, one ground for denying or ignoring a connection request isthat analyte sensor system 308 is already connected to a display device310 or a partner device 315. If there are no grounds for denying orignoring a connection request, analyte sensor system 308 may accept therequest and connect to the display device 310 or partner device 310 thatsent the request. For example, operation 1005 b shows analyte sensorsystem 308 accepting the request by sending signaling to display device310 or partner device 315 to indicate that the connection request isgranted. Aspects of advertisement and related contexts are alsoillustrated by way of example with reference to FIGS. 6, 7A-7C. (See,e.g., operations 1065 a, 1095 a.) Detailed discussions of these FIGS.are included further below.

Referring further to FIG. 7A, once display device 310 (or partner device315) and analyte sensor system 308 are connected, messaging may beexchanged, including for example, analyte sensor system 308 transmittinganalyte data to display device 310 or partner device 315. By way ofexample, reference is made to operation 1005 d shown in FIG. 7A. Inembodiments, in order to prevent display device 310 or partner device315 from staying connected to analyte sensor system 308 longer than isexpected or desired, analyte sensor system 308 may enforce timeouts,and/or may cause timeouts to be enforced. That is, for example, theremay be a predetermined limit set with respect to the duration of theconnection, and upon the expiry of the same, the connection to analytesensor system 308 may be terminated. By way of example, reference ismade to operation 1015 shown in FIG. 7A, at which a data connection isclosed and, optionally, transceiver 410 is deactivated. Terminating theconnection may allow a connection or at least a connection attempt to bemade vis-à-vis analyte sensor system 308 and other display devices 310and/or partner devices 315. Analyte sensor system 308 may maintain alist of display devices 310 and/or partner devices 315 that haverecently connected to analyte sensor system 308. In some cases, this maybe known as a whitelist. Analyte sensor system 308 may use this list topermit only listed display devices 310 and/or partner devices 315 (i.e.,that have recently connected, or that are otherwise listed) to connectto analyte sensor system 308.

FIG. 6 is a timing diagram illustrating an example of the transmissionof advertisement messages in accordance with embodiments of the presentdisclosure. More specifically, FIG. 6 provides an example ofadvertisement duration structure 622 that may be used in connection withpairing or establishing a connection among/between analyte sensor system308, display devices 310, and/or partner devices 315. In connection withthe above and in accordance with embodiments of advertisement durationstructure 622, advertisement messages 618 may be sent according to atime interval that occurs periodically based on a schedule. This may bereferred to herein in some cases as an advertisement window interval612. The period of repetition of the occurrence of advertisement windowinterval 612 may be any length of time.

In embodiments, advertisement window interval 612 may be configured orset to vary depending upon the nature of the operation of analyte sensorsystem 308 with respect to gathering and processing analyte data and/ordepending upon the nature of operation of partner device 315 vis-à-visthe administration of medicaments, and/or based on other considerations.In example implementations, advertisement window interval 612 may beconfigured or set to vary based upon whether partner device 315 isconnectable to analyte display device 308. In example implementations,advertisement window interval 612 may be configured or set to vary basedupon system requirements 650 of partner device 315. In exampleimplementations, advertisement window interval 612 may be configured orset to vary based upon the network topology of a system wherein analytesensor system 308 is in communication with one or more of partnerdevices 315, display devices 310, and server system 334 (e.g., system200, with reference to FIG. 2A, system 800, with reference to FIG. 8,and/or system 900, with reference to FIG. 9A). For example,advertisement window interval 1012 may be configured or set to varybased upon a number of display devices 310 connectable to analyte sensorsystem 308, based upon whether partner device 315 is an automaticinsulin delivery device, and/or based upon system requirements 650 of apartner device 315 that is an automatic insulin delivery device. In onespecific example, advertisement window interval 612 is approximately 5minutes. Thus, in this specific example, every 5 minutes, there will bea time window for advertisement messages 618 to be transmitted.

The time window for advertisement messages 618 may be considered aduration of time during which advertisement messages 618 may actually betransmitted. This may also be referred to in some cases as advertisementduration 614. By way of example, in some example implementations,advertisement duration 614 may range from 7 to 22 seconds in length. Itwill be appreciated by one of ordinary skill in the art upon studyingthe present disclosure, however, that the length of advertisementduration 614 (in time) may range from 0 to any reasonable amount oftime. In some cases, advertisement duration 1014 is shorter thanadvertisement window interval 612. This may change, however, based uponsystem configurations/requirements discussed in detail elsewhere herein.

During advertisement duration 614, advertisement messages 618 may betransmitted, in some cases periodically, though not necessarily so,according to advertisement message interval 616. Advertisement messageinterval 616 may be thought of as a time interval between sequential orsuccessive transmissions of advertisement messages 618. One specificexample range for advertisement message interval 616 is between 20 and90 msec, though it will be appreciated upon studying the presentdisclosure that advertisement message interval 616 may be shorter orlonger, and/or may be adaptively variable, programmable, and/orconfigurable in length, depending on the relevant circumstances,including adapting or (re)configuring advertisement message interval 616during advertisement duration 614.

In embodiments, advertisement message interval 616 may be configured orset to vary depending upon the nature of the operation of analyte sensorsystem 308 with respect to gathering and processing analyte data and/ordepending upon the nature of operation of partner device 315 vis-à-visthe administration of medicaments, and/or based on other considerations.In example implementations, advertisement message interval 616 may beconfigured or set to vary based upon whether partner device 315 isconnectable to analyte display device 308. In example implementations,advertisement message interval 616 may be configured or set to varybased upon system requirements 650 of partner device 315. In exampleimplementations, advertisement message interval 616 may be configured orset to vary based upon the network topology of a system wherein analytesensor system 308 is in communication with one or more of partnerdevices 315, display devices 310, and server system 334 (e.g., system200, with reference to FIG. 2A, system 800, with reference to FIG. 8,and/or system 900, with reference to FIG. 9A). For example,advertisement window interval 612 may be configured or set to vary basedupon a number of display devices 310 connectable to analyte sensorsystem 308, based upon whether partner device 315 is an automaticinsulin delivery device, and/or based upon system requirements 650 of apartner device 315 that is an automatic insulin delivery device.

After advertisement window interval 612 has elapsed, advertisementmessages 1018 may resume transmission, and advertisement durationstructure 622 may be repeated (e.g., as advertisement duration structure622′). It should also be noted that one or more of the advertisementmessage interval 616, advertisement duration 1014, and advertisementwindow interval 612 can be reconfigured as between advertisementduration structures 622 and 622′ and/or within the respectiveadvertisement durations of advertisement duration structures 622, 622′(e.g., 614, etc.).

The above-mentioned features of advertisement duration structure 622,including advertisement window interval 612, advertisement duration 614,and advertisement message interval 616, can each vary based on a varietyof factors. For example, the values of these parameters may vary basedon the type and/or number of display devices 310 present, as well asbased on the system requirements of such display devices 310, and/or onhow recently such display devices 310 have connected to analyte sensorsystem 308. As another example, the values of these parameters may varybased on the type and/or number of partner devices 315 present, as wellas based on system requirements 650 and/or other characteristics of suchpartner devices 315 (e.g., whether automatic insulin delivery is beingprovided). The values of these parameters can also vary in order tooptimize connection reliability, accuracy, battery life, to speed upconnection time, etc. of display device 310 and/or partner device 315.Any one of a decreased advertisement window interval 612, an increasedadvertisement duration 614, and a decreased advertisement messageinterval 616, may increase the likelihood that a connection can besuccessfully established as between a particular display device 310and/or partner device 315, and analyte sensor system 308 or otherdevice. In examples, however, there may be a concomitant increase inpower consumption with changing the parameters in this manner.

It should also be appreciated that one or more advertisement durations614 may be specifically allocated to a particular display device 310 orpartner device 315 for connection. Accordingly, by revoking theallocation of advertisement durations 614 from specific devices, or bynot allocating advertisement durations 614 to such devices in the firstplace, it is possible to prevent a connection from being established asbetween such devices and analyte sensor system 308. This may be donewhere, for example, a dedicated connection is desired between partnerdevice 315 and analyte sensor system 308, where such dedicatedconnection may be substantially free from potential interferenceintroduced by devices other than partner 315 responding toadvertisements send by analyte sensor system 308.

Accordingly, aspects of the present disclosure include configuringadvertisement duration structure 622, including configuringadvertisement window interval 612, advertisement duration 1014, and/oradvertisement message interval 616, and other features associated withadvertisement messaging and/or related thereto. Aspects of the presentdisclosure also include controlling the allocation of advertisementdurations 614 to specific devices (e.g., display device 310 and/orpartner device 315), in order to create dedicated advertisement slotsfor such specific devices.

The foregoing aspects of the present disclosure may be used to increasethe likelihood of successfully establishing a connecting with analytesensor system 308. In addition, configuring advertisement duration 612and/or controlling the allocation of advertisement durations 614 mayalso reduce power consumption involved with connection establishment,due to increased efficiency of the connection protocol. In this manner,the overall reliability of communications related to analyte data and/ormedicament delivery can be increased, while the power consumption can bedecreased. In embodiments, the above-described aspects of advertisementmessaging can be configured to effect intelligent tradeoffs amongreliability, speed, power consumption/efficiency, and so forth,including where such tradeoffs may be implemented dynamically based on,for example, system requirements 650 of partner devices 315 that may beunknown prior to partner devices 315 attempting to establish connectionswith analyte sensor system 308.

It should also be appreciated here that with respect to the abovefeatures of connection establishment and/or advertisement messaging, inaddition to analyte sensor system 308 transmitting advertisementmessages to display devices 310 and/or partner devices 315 forconnection establishment purposes, display devices 310 and/or partnerdevices 315 may send advertisement messages for connection establishmentpurposes as well. In such instances, it will be understood upon studyingthe present disclosure that the above features may be similarlyemployed.

G. Connection Models

As alluded to above, aspects of the present disclosure also includevarious connection models for communications between or among analytesensor system 308, display devices 310, server system 334, and/orpartner device 315. One connection model for communications may bereferred to as an intermittent connection model (or in some cases aconnect/disconnect model). In accordance with an intermittent connectionmodel, communications between/among analyte sensor system 308, displaydevice 310, server system 334, and/or partner device 315 may be periodicor intermittent in nature, following a defined orevent-based/asynchronous schedule. For example, display device 310and/or partner device 315 may establish connection with analyte sensorsystem 308 periodically (e.g., once every five minutes) in order toexchange analyte and/or other data with analyte sensor system 308.

In example implementations, rather than having the transmission andreceiving circuitry of analyte sensor system 308, display device 310,and/or partner device 315 continuously communicating, analyte sensorsystem 308, display device 310, and/or partner device 315 mayintermittently, regularly, and/or periodically establish a communicationchannel between/among them. Thus, for example, analyte sensor system 308can in some cases communicate via wireless transmission with displaydevice 310 and/or partner device 315 at predetermined time intervals.The duration of the predetermined time interval can be selected to belong enough so that analyte sensor system 308 does not consume too muchpower by transmitting data more frequently than needed, yet frequentenough to provide substantially real-time sensor information (e.g.,measured glucose values or analyte data) to display device 310 foroutput (e.g., via a display as part of user interface 435) to a userand/or to partner device 315 for example for use in the administrationof medicaments. While the predetermined time interval may be for exampleevery five minutes in some embodiments, it should be appreciated thatthis time interval can be varied to be any desired length of time (e.g.,as discussed above in connection with FIG. 6).

In embodiments, the intermittent connection model may result in powersavings relative to other connection models. Accordingly, if batterypower is a primary concern relative to packet loss and/or latency etc.,then the intermittent connection model may be preferable to thecontinuous connection model. Additionally, it will be appreciated thataccording to the intermittent connection model, display devices 310and/or partner devices 315 in example implementations are not connectedto analyte sensor system 308 at the same time. Rather, different displaydevices 310 and/or partner devices 315 in some cases connect fordifferent, limited amounts of time. Which display devices 310 and/orpartner device 315 may connect and when such devices can connect toanalyte sensor system 308 may be controlled, for example, using a listsuch as a whitelist and/or by modifying the advertising structureemployed, as described above with reference to FIG. 6. Accordingly, insome situations, the intermittent model may be suitable and/orpreferable. One such situation may be if a user prefers to monitor ananalyte value using multiple display devices 310. For example, if theuser has Type 1 diabetes, monitoring of analyte (e.g., glucose) data maybe relatively more critical, and hence, multiple display devices 310 maybe employed for greater coverage/redundancy.

FIG. 7A is an operational flow diagram illustrating various operationsthat may be performed in connection with embodiments of method 700 forwireless communication of analyte data between/among analyte sensorsystem 308, display device 310, server system 334, and/or partner device315, according to the intermittent connection model described above.Features of method 700 can also be applied in connection withembodiments of related systems, apparatuses, and devices. Morespecifically, as shown in FIG. 7A, communication session 720 may involveoperations 1005 a through 1015, though in embodiments, not all of theseoperations are necessarily performed.

The various tasks performed in connection with the procedure illustratedin FIG. 7A may be performed, for example, by processors 430, 530, and/or630 executing instructions embodied respectively in storage 415, 515,and/or 615 (which may include, e.g., non-transitory computer-readablemedia). The tasks or operations performed in connection with theprocedure may be performed by hardware, software, firmware, and/or anycombination thereof incorporated into one or more computing devices,such as one or more of analyte sensor system 308, display device 310,server system 334, and/or partner device 315.

It will be appreciated upon studying the present disclosure that theprocedure may include any number of additional or alternative tasks oroperations. This is generally but not necessarily always true for allthe procedures and/or methods described herein. The operations shown byway of example in FIG. 7A need not necessarily be performed in theillustrated order, and the procedure may be incorporated into a morecomprehensive procedure or process having additional functionality notdescribed in detail herein with specific reference to FIG. 7A. Again,this is generally but not necessarily always true for all the proceduresand/or methods described herein.

In some examples described below, the analyte values are glucose valuesbased on one or more measurements made by analyte sensor system 308and/or sensor 535 (with reference to FIG. 3C). Nevertheless, it shouldbe understood upon studying the present disclosure that in embodimentsthe analyte values can be any other analyte value described herein orknown in the art. The wireless data communication between analyte sensorsystem 308, display devices 310, server system 334, and/or partnerdevices 315 may happen periodically, at times separated by an updateinterval denoted “T_(interval)” that may correspond to a time durationbetween consecutive wireless communication sessions between thetransceiver 510 of analyte sensor system 308 (referencing FIG. 3C),transceiver 410 of display device 310 (referencing FIG. 4), and/ortransceiver 610 of partner device (referencing FIG. 5B). Alternativelyor additionally, the update interval may be thought of as a period ofobtaining and sending a recently measured or generated glucose value,medicament-related, or other data. Transmitting advertisement signals ormessages, establishing a data connection (e.g., a communication channel)and requesting and sending data may occur during wireless communicationsessions each lasting an active time or period denoted “T_(Active)”within an update interval T_(interval). One caveat here is thatT_(interval) and/or T_(Active) can vary as between sessions. In betweenconsecutive wireless communication sessions, components of analytesensor system 308 (e.g., transceiver 510), of display device 310 (e.g.,transceiver 410), and/or of partner device 315 (e.g., transceiver 610)may enter a low power mode or a like mode, such as an inactive or sleepmode, for an inactive period denoted as “T_(Inactive)”. This may enablethe conservation of battery life and/or reduce peak voltagerequirements, for example.

Accordingly, in some connection schemes used for the communication ofanalyte data, medicament data, and/or other data and control signaling,a connection may be periodically established between/among analytesensor system 308, display device 310, server system 334, and/or partnerdevice 315. For example, with further reference to FIG. 7A,communication session 720 may implement one such connection scheme (thatoptionally includes authentication). More specifically, communicationsession 720 may be implemented during a time interval T_(interval). Asalluded to above, T_(interval) may include an active portioncorresponding to T_(Active) and an inactive portion corresponding toT_(Inactive). Generally speaking, during T_(Active), analyte sensorsystem 308 and display device 310 and/or partner device 315 areconnected and actively exchanging messaging (e.g., pursuant to operation1005 and/or sub-operations thereof), though there may be periods duringT_(Active) during which analyte sensor system 308, display device 310,and/or partner device 315 enters a low power mode or the like, asdescribed above.

In terms of connecting, in example implementations, analyte sensorsystem 308 may transmit one or more advertisement messages at operation1005 during communication session 720. An advertisement message may beconsidered as an invitation for display device 310 and/or partner device315 to establish a data connection with analyte sensor system 308 (e.g.,via transceiver 510). Example structures for advertisement messages thatin some cases may be transmitted for purposes of establishing aconnection between two devices, according to various aspects of thepresent disclosure are above in connection with FIG. 6, and in U.S.Provisional Application Nos. 62/364,771 and 62/409,677, which areincorporated herein by reference in their entireties. The transmittedadvertisement messages may then be received at display devices 310(e.g., via transceiver 410) and/or partner devices 315 (e.g., viatransceiver 610).

As alluded to above, during communication session 720, an authenticationprocedure may optionally be performed in connection with a dataconnection process corresponding to operation 1005 b and/or a datatransmission process corresponding to operation 1005 d. To establish adata connection with analyte sensor system 308, display device 310and/or partner device 315 may listen or scan until an advertisementmessage transmitted by analyte sensor system 308 is received.Accordingly, operation 1005 b may involve analyte sensor system 308receiving a connection request from display device 310 and/or partnerdevice 315 and responding thereto by granting or denying the request. Ifanalyte sensor system 308 grants the connection request, anacknowledgement or other message may be transmitted to display device310 and/or partner device 315 as part of operation 1005 b. Then, a dataconnection between analyte sensor system 308 and display device 310and/or partner device 315 may be established.

According to operation 1005 c, an authentication procedure may beemployed before data is actually exchanged at operation 1005 d.Authentication may involve the exchange of various messages, includingchallenge and hash values and signaling related thereto, between analytesensor system 308 and display device 310 and/or partner device 315, inaccordance with a one-way or two-way handshake process per operation1005 c. Once authenticated, analyte sensor system 308 and display device310 and/or partner device 315 may exchange information to determine howdata will be exchanged (e.g., a specific frequency, time slotassignment, encryption, etc.). Further, communication session 720 mayalso include exchanging an application key between analyte sensor system308 and display device 310 and/or partner device 315. By the exchange ofchallenge and hash values described in connection with operation 1005 c,such an application key may effectively be shared between analyte sensorsystem 308 and display device 310 and/or partner device 315. Thus, inembodiments, the application key may be used for both authentication andencryption purposes.

With further reference to FIG. 7A, after completion of the optionalauthentication process according to operation 1005 c, analyte sensorsystem 308 and connected display device 310 and/or partner device 315may engage in data communication at operation 1005 d, during whichconnected display device 310 and/or partner device 315 may request andreceive desired information (e.g., analyte data, control information,identification information, and/or instruction) from analyte sensorsystem 308 and/or may send information including command and controlsignaling or other information, such as for example medicament-relatedinformation. When data communication at operation 1005 d is completed,the data connection may be terminated at operation 1015 (e.g., byclosing the established communication channel).

In other circumstances, however, a continuous connection model may besuitable and/or preferable relative to the intermittent connection modeldescribed above. At a high level, the continuous connection model caninvolve an initial pairing between analyte sensor system 308 and displaydevice 310 and/or partner device 315, after which analyte sensor system308 and display device 310 and/or partner device 315 remain connected,essentially not closing the connection or disconnecting. That is,connection and the exchange of data in example implementations is notdone periodically or intermittently as with the intermittent connectionmodel (e.g., as discussed with reference to FIG. 7A), but instead, theconnected devices periodically exchange messaging to maintain theconnection. Once data is available at analyte sensor system 308, thedata can be transmitted to display device 310 and/or partner device 315in near or at least near real time. In this manner, the overall accuracyand responsiveness of communications related to analyte data may beincreased. An additional advantage associated with the continuousconnection model is that analyte sensor system 308 may be enabled tobetter mitigate against interferences caused by undesired devices (e.g.,in some cases, undesired display devices 310) seeking to connect withanalyte sensor system 308. Hence, reliability of data exchange androbustness of connection may be increased, which may be particularlyimportant where a user is relying upon partner device 315 for theadministration of medicaments such as insulin.

By way of example, the potential increase in reliability of dataexchange may be beneficial, for example, where partner device 315 is aninsulin pump used to automatically deliver insulin to a user based onanalyte data generated using analyte sensor system 308 and transmittedto partner device 315. In some such cases, connectionreliability/robustness between analyte sensor system 308 and partnerdevice 315 may be more critical relative to the ability to establishconnections with multiple display devices 310, and as mentioned above,connection requests from display devices 310 may cause interference witha connection, or the establishment of a connection, between partnerdevice 315 and analyte sensor system 308. The continuous connectionmodel as employed, for example, between analyte sensor system 308 andpartner device 315 may serve as a means for increasing connectionreliability/robustness and may thus be preferable for certainembodiments involving partner device 315, as well as in other situationsdescribed and/or alluded to herein.

Accordingly, embodiments of the present disclosure include employing acontinuous connection model between certain devices. Such a connectionmodel may in some cases reduce latency between the collection and/orgeneration of analyte data at analyte sensor system 308 and thetransmission of such data and related data and control signaling todisplay devices 310 and/or partner devices 315 connecting thereto, aswell as exchange of medicament-related data and control signaling, whilemaintaining a sufficiently low power consumption for analyte sensorsystem 308. Furthermore, as mentioned above, the continuous connectionmodel may increase reliability/robustness and predictability of theconnection between analyte sensor system 308 and display device 310and/or partner device 315.

In this connection, FIG. 7B illustrates example implementations ofmethod 702 for wireless communication of analyte data among/betweenanalyte sensor system 308 and display device 310 and/or partner device315 according to example implementations of the continuous connectionmodel alluded to above. Communication session 740 can be initiated inconnection with method 702. More specifically, as shown in FIG. 7B,communication session 740 may involve operations 1095 a through 1095 gand/or 1095 a′, though in embodiments, not all of these operations arenecessarily performed.

As with FIG. 7A, the various tasks performed in connection with theprocedure illustrated in FIG. 7B may be performed, for example, byprocessors 430, 530, and/or 630 executing instructions embodiedrespectively in storage 415, 515, and/or 615 (which may include, e.g.,non-transitory computer-readable media). The tasks or operationsperformed in connection with the procedure, an in general but notnecessarily always in connection with all procedures, operations, andmethods described herein, may be performed by hardware, software,firmware, and/or any combination thereof incorporated into one or morecomputing devices, such as one or more of analyte sensor system 308,display device 310, server system 334, and/or partner device 315. Itwill be appreciated upon studying the present disclosure that theprocedure may include any number of additional or alternative tasks oroperations. The operations shown by way of example in FIG. 7B need notnecessarily be performed in the illustrated order, and the procedure maybe incorporated into a more comprehensive procedure or process havingadditional functionality not described in detail herein with specificreference to FIG. 7B.

With respect to the continuous connection model, analyte data may bedropped or lost if the connection between/among analyte sensor system308 and display device 310 and/or partner device 315 is not maintained.This may in turn lead to improper or inaccurate representation ofanalyte information, such as estimated glucose values, and in somecases, may lead to administration of medicaments that is not as accurateor precise as desired. Thus, embodiments herein related to thecontinuous connection model involve sustaining and/or maintaining aconnection established between/among analyte sensor system 308 anddisplay device 310 and/or partner device 315. Further, with respect tomaintaining the connection, it may at times be useful to monitor theconnection status to derive and/or provide an indication regarding thesame. One way this may be done is using connection parameters.

At operation 1095 a, method 702 may involve activating a transmitter ofanalyte sensor system 308 and/or transmitting advertisement messages.This transmission of advertisement messages may be substantially similarto operation 1005 a described above. The advertisement messagestransmitted at operation 1095 a may be received by one or more displaydevices 310 and/or partner devices 315, for example.

At operation 1095 b, a connection may be established between analytesensor system 308 and display device 310 and/or partner device 315responding to the advertisement messages. As part of operation 1095 b,connection parameters can be exchanged between analyte sensor system 308and display device 310 and/or partner device 315. In this regard,analyte sensor system 308, display device 310, and/or partner device 315may propose and set up a set of connection parameters upon which aspectsof a connection with analyte sensor system 308 may be based.

Examples of connection parameters include a connection interval (in somecases referred to herein as a pinging interval), slave latency, andsupervision timeout. Analyte sensor system 308 and/or display device 310and/or partner device 315 can use one or more of such connectionparameters to maintain a connection continuously exchanging data, forexample related to analyte levels, medicament delivery, related controlsignaling, system configuration signaling, etc. Additional connectionparameters may relate to control signaling, such as mode control fordisplay devices 310 and/or partner devices 315, and/or control signalingrelated to network topologies that may be implemented in accordance withembodiments described herein.

Following a connection decision that results in establishing aconnection, at operation 1095 c, method 702 may optionally involveauthentication. At operation 1095 d, embodiments of method 702 includeexchanging data between/among analyte sensor system 308, display device310, and/or partner device 315. With respect to the continuousconnection model, operation 1095 d may be repeated periodically, as databecomes available for transmission (e.g., in some cases aperiodically),and/or whenever data is requested to be exchanged (e.g., on-demand). Theexchange of data according to operation 1095 d may be interspersed withthe exchange of other messaging, such as, for example, ping messaging orother control-related messaging exchanged with analyte sensor system308. In FIG. 7B, this may be represented by way of example using theoperations intervening operation 1095 d and 1095 d′ (i.e., operations1095 e and 1095 f), though certain types of control signaling may not beexplicitly illustrated.

In embodiments, connection parameters agreed upon in conjunction withconnection establishment (e.g., as part of operation 1095 b), as well asother configuration aspects, can be updated/modified subsequently, forexample, after a connection decision is made. Accordingly, at operation1095 f, method 702 may involve updating one or more of the connectionparameters. As shown at operation 1095 g, in some cases, the connectionwith analyte sensor system 308 may be terminated or lost. There may bevarious causes for this. In response to connection being lost atoperation 1095 g, analyte sensor system 308 may send advertisementmessages according to operation 1095 a′. In accordance with exampleembodiments of the continuous connection model, upon analyte sensorsystem 308 and display device 310 and/or partner device 315 becomingdisconnected, analyte sensor system 308 may resume sending advertisementmessages in some cases at least almost immediately.

A user of display device 310 and/or partner device 315 may not be awarethat there has been a disconnection according to operation 1095 g. Thismay in some cases lead to packet drop or data loss. Thus, in some cases,analyte sensor system 308 may resume advertisement automatically withoutuser intervention. Alternatively or in addition, the user may receive anotification via analyte sensor system 308, display device 310, and/orpartner device 315 that the connection has been lost.

FIG. 7C shows that, in addition to the intermittent connection model andthe continuous connection model, embodiments of the present disclosurealso involve communications of data through broadcasting of packets,where no connection establishment as such is necessary. The broadcast ofdata packets, as will be described more fully herein, can beparticularly useful where certain devices connectable to analyte sensorsystem 308, e.g., display devices 310, are set in a display only statewhile another connectable device(s), e.g., partner device 315, is hasestablished a connection to and is exchanging data and command/controlmessaging with analyte sensor system 308.

In FIG. 7C, method 706 for wireless communication of analyte-relateddata, medicament-related data, and/or other information between/amonganalyte sensor system 308, display device 310, and/or partner device 315is illustrated in connection with implementations of the presentdisclosure. Example embodiments of method 706 involve establishing afirst connection between, for example, analyte sensor system 308 anddisplay device 310 and/or partner device 315. This is optional and mayoccur in connection with communication session 720 corresponding toT_(interval). As such, establishing the first connection can optionallyinclude authentication between analyte sensor system 308 and displaydevice 310 and/or partner device 315.

Method 706 also includes establishing communication session 760 that maybe implemented during a time interval T_(interval)′, which may be thesame as or different from T_(interval). T_(interval)′ may include anactive portion corresponding to T_(Active)′ and an inactive portioncorresponding to T_(Inactive)′. During T_(Active)′, communicationsession 760 may involve operation 1065 and sub-operations thereof.

Here it should be noted that, as mentioned above, communication session760 may not include establishment of a connection between/among analytesensor system 308, display device 310, and/or partner device. Forexample, communication session 760 as illustrated does not include thedata connection aspects of operation 1005 b shown in FIG. 7A inconnection with communication session 720. Nor does communicationsession 760 as illustrated include the authentication process that maybe included in communication session 720 (e.g., at operation 1005 c).Rather, at operation 1065 a, method 706 involves sending one or moreadvertisement messages to display device 310 and/or partner device 315.

As such, as part of communication session 760, analyte sensor system 308may transmit a first advertisement message (e.g., operation 1065 a). Thefirst advertisement message may include at least a first portion of ananalyte value. The analyte value may but need not have been encrypted(e.g., using an application key) prior to transmission. In other words,with regard to communication session 760, analyte sensor system 308 mayuse one or more advertisement messages to transmit encrypted ornon-encrypted analyte values or analyte data and/or other signaling(such as, e.g., timing and control information) in addition to otherinformation that may be included in advertisement messages.

In some cases, an advertisement message may take the form of a packet.By way of example, the analyte value (whether encrypted or not) may beincluded in a reserved or other field in the advertisement messagepacket, and/or may be encoded into the packet. The advertisement messagemay also or additionally include other information, such as for examplea time stamp associated with the analyte value. In exampleimplementations, method 706 may involve breaking the payload, which mayinclude the (encrypted) analyte value and associated data, into multipleparts. The first advertisement message may then indicate that a secondadvertisement message includes a second portion of the analyte valueand/or associated data. The first advertisement may so indicate bytagging the first portion of the payload, where the tag represents thata subsequent advertisement message may include a second portion of thepayload.

In other words, according to communication session 760, advertisementmessages may be transmitted in connection with operation 1065 a for thepurposes of communicating analyte and/or other data to display devices310 and/or partner devices 315. With the payload encrypted using anapplication key, privacy/security can be maintained even in the absenceof authentication procedures being performed during communicationsession 760. Likewise, because the payload is included in theadvertisement messages, the data connection request and datatransmission processes (e.g., operations 1005 b and 1005 d,respectively, with reference to FIG. 7A) can also be bypassed oravoided. In this manner, the number of messages exchanged in pursuant tocommunication session 760 (and hence the power consumption) may bereduced relative to other communication sessions. Additionally, forexample, analyte and other data may be provided to display devices 310even while partner device 315 maintains a dedicated connection toanalyte sensor system 308 and acts as the only device with permission tosend command and control signaling to analyte sensor system 308 (e.g.,calibration commands related to a sensor session).

With further reference to FIG. 7C, communication session 760 may alsoinclude, at operation 1065 b, display device 310 and/or partner device315 acknowledging receipt of the advertisement message(s) sent duringoperation 1065 a, by sending an acknowledgement (ACK) message. In somecases, this acknowledgement may trigger a data connection processbetween analyte sensor system 308 and the acknowledging display device310 and/or partner device 315. For example, analyte sensor system 308may in turn send an ACK to display device 310 and/or partner device 315and thus establish a connection therewith. This data connection process,in example deployments, may be used for renewing the application and/orencryption key(s) and/or for exchanging other data, such as, forexample, calibration data, timing information, exchange of permissions,mode control signaling, and the like. When communications at operation1065 are completed, data transmission may be terminated at operation1075. At this point, transceiver 510 and/or processor 530 of analytesensor system 308 can be deactivated. In FIG. 7C, this generallycorresponds to operation 1075 and is denoted as T_(Inactive)′.

As mentioned above, there may be various tradeoffs as between theintermittent connection model and the continuous connection model. Forexample, battery power may in some cases be more rapidly consumed if thecontinuous connection model is employed, though reliability/robustnessmay in some cases be increased. Thus, it may be preferable in some casesto switch to the intermittent connection model. In another example, dueto multiple connection requests/acknowledgments, operating in theintermittent connection model may lead to an increased chance ofdropped/lost data. Thus, it may be preferable in some cases to switch tothe continuous connection model. In additional examples, thecontrol/command signaling permissions for a particular device may bechanged, for example due to network topology and/or operating modechanges, and in such cases the connection model may be changed(including, e.g., to from the advertisement broadcast scheme describedwith reference to FIG. 7C).

Accordingly, embodiments of the present disclosure involve switchingbetween these connection models in order to provide a flexible andadaptable system that may be optimized for a variety of uses, operatingconditions, and user/system preferences. Switching adaptively (whetherin an automated fashion or based on user input, both of which arecontemplated herein) may allow for optimization of battery power usageas well as transmission efficiency and data accuracy and connectionreliability/robustness. In addition, device performance and behaviorcan, in accordance with example embodiments, be tracked over time and beused to develop an optimization profile with respect to circumstances inwhich various connection models may be preferable.

In some cases, the connection model may be switched on an automatedbasis depending on various criteria. For example, the connection modelmay be set depending upon the type of display device 310 and/or partnerdevice 315 being connected to analyte sensor system 308. For example,the connection model may be set based on the number of display devices310 being used—e.g., if a single, dedicated device is being used (e.g.,for a predetermined amount of time), then the system may switch to thecontinuous connection model. Or, if many display devices 310 are beingused, a number of the display devices 310 may utilize communicationsession 740. In another example, the connection model may be switchedbased upon current or projected battery life of analyte sensor system308, display device 310, and/or partner device 315. The quality ofexchanged signals may also be used to determine whether a switch betweenconnection models is appropriate. Further, a switch in connection modelsmay be based on the time of day and/or the location of analyte sensorsystem 308, partner device 315, and/or display device 310. The switchcould be initiated by display device 310, partner device 315, and/oranalyte sensor system 308 (e.g., using mode control signaling).

In embodiments, the switch may be based on user input or may besemi-automatic. For example, a user may navigate a GUI provided by userinterface 435 of display device 310 to implement the switch. In anotherexample, the switch may be triggered automatically or without userintervention (e.g., by or in response to partner device 315), in turntriggering a prompt being presented to the user on display device 310via the GUI of user interface 435. The user may then approve or deny theswitch (thus, the switch can be made semi-automatic). The prompt mayprovide the user with information regarding the connection modelcurrently employed, the reason for the proposed switch, and in somecases the consequences of rejecting and/or accepting the proposedswitch, including tradeoffs related to the same. In other examples, noprompt may be provided to the user.

Turning now to FIG. 7D, embodiments of the present disclosure involveconfiguring and/or setting up a kind of mesh network using various ofthe connection models described herein (e.g., with reference to FIGS.7A-7C). For example, display devices 310 and/or partner device 315(and/or a plurality of either device) can be in connection with analytesensor system 308 using different connection models. With reference toFIG. 7D and the illustrated example of system 304, analyte sensor system308 may be connectable to display device 310 and/or partner device 315via communication media 305 (referencing FIG. 2B). Further, displaydevice 310 and partner device 315 may be connectable to one another viacommunication media 305 (again referencing FIG. 2B). It will beappreciated that although reference is made here to communication media305, additional communication media and/or links may be included in themesh-like networks described herein, and/or using various connectionmodels (e.g., communication media 305 a, 305 b, etc., referencing FIG.2B).

Referring again to FIG. 7D, for example, communication session 740 canbe employed as between analyte sensor system 308 and partner device 315,while at the same time a different communication session (e.g., 720,760, etc.) can be employed as between display devices 310, on the onehand, and analyte sensor system 308 on the other hand. Further still,yet another communication session can be employed between displaydevices 310 and partner devices 315. FIG. 7D shows that in connectionwith system 304, analyte sensor system 308 may be connectable to displaydevice 310 and/or partner device 315 using various communication media(e.g., communication media 305) and/or connection models (e.g.,intermittent connection model, continuous connection model, etc., asdiscussed in further detail with reference to FIGS. 7A-7C), representedby way of illustration as Connections A and B. Additionally, displaydevice 310 and partner device 315 may be connectable to one anotherusing various communication media 305 and/or connection models,represented by way of illustration here as Connection C. Certain detailsof the continuous connection and intermitted connection models arediscussed in further detail in U.S. Provisional Application Nos.62/364,771 and 62/409,677, both of which are incorporated herein byreference in the their entirety.

For example, when display device 310 and partner device 315 are in rangeand connectable to analyte sensor system 308, analyte sensor system 308and display device 310 may connect using the intermittent connectionmodel (e.g., Connection A), and partner device 315 may connect toanalyte sensor system 308 using the continuous connection model (e.g.,Connection B). Under the intermittent connection model, by way ofexample, display device 310 periodically connects with analyte sensorsystem 308, exchanges data therewith, and then disconnects. Under thecontinuous connection model, by way of example, partner device 315 andanalyte sensor system 308 establish a connection and then continuouslyexchange signaling to maintain that connection while data is exchanged.By way of further example, with the intermittent connection model, theremay be a chance that between subsequent periodic connections, otherdevices connect to analyte sensor system 308 or attempt to do sosimultaneously with display device 310, such that display device 310 maybe unsuccessful in reconnecting with analyte sensor system 308 (avariety of other circumstances may lead to this as well). By contrast,under the continuous connection model, typically barring a severe event,the connection between partner device 315 and analyte sensor system 308is more likely to be maintained and not interrupted. In this manner,partner device 315 may maintain a more reliable, prioritized connectionwith analyte sensor system 308 and may have a better quality of servicesas a result. As such, for example patient-critical applications such asthe automated delivery of insulin by partner device 315, it may be thecase that the continuous connection model is preferred as betweenpartner device 315 and analyte sensor system 308.

With further reference to FIG. 7D, partner device 315 and display device310 may maintain communication via Connection C, using any of theconnection models described herein. Thus, partner device 315 candirectly share medicament delivery data and other information withdisplay device 310. It will further be appreciated here that therespective connection models used by display device 310 and partnerdevice 315 to connect to analyte sensor system 308 may switch. It willalso be appreciated that both display device 310 and partner device 315can connect to analyte sensor system 308 using the intermittentconnection model or the continuous connection model. It should also beappreciated and will be discussed herein that in embodiments, that oneor more of analyte sensor system 308, display device 310, and partnerdevice 315 may use the advertisement broadcast connection scheme ofcommunication session 760 for any of Connection A, B, and/or C in system304.

Regardless of the connection models employed between analyte sensorsystem 308, on the one hand, and display device 310 and/or partnerdevice 315 on the other hand, display device 310 and partner device 315may connect to one another using any of the intermittent connectionmodel, the continuous connection model, and/or the advertisementbroadcast connection scheme of communication session 760 (referencingFIG. 7C). Furthermore, any of the communication media and/or connectionmodels employed (e.g., in Connections A, B, and C) can switch to adifferent connection model subsequent to connection establishment,including in a subsequent communication session.

H. Overview of Alerts

In certain embodiments, one or more alerts, alarms, and/or notifications(in some cases, simply “alerts”) are associated with analyte sensorsystem 308, display device 310, and/or partner device 315. For example,alerts may involve one or more alert conditions that indicate when therespective alert has been triggered. Alerts may be triggered based oncharacteristics of analyte data generated using analyte sensor system308. For example, a hypoglycemic alert may include alert conditionsindicating a minimum glucose level. The alert conditions may also bebased on transformed sensor data, such as trending data, and/or sensordata from multiple different sensors (e.g., an alert may be based onsensor data from both a glucose sensor and a temperature sensor). Forexample, a hypoglycemic alert may include alert conditions indicating aminimum required trend in the host's glucose level that must be presentbefore triggering the alert. The term “trend,” as used herein refersgenerally to data indicating some attribute of data that is acquiredover time, e.g., such as calibrated or filtered data from a continuousglucose sensor. A trend may indicate amplitude, rate of change,acceleration, direction, etc., of data, such as sensor data, includingtransformed or raw sensor data.

In embodiments, alerts may be triggered based on events or conditionsmonitored or detected at partner device 315. For example, an alert maybe triggered if it is determined (e.g., based on self-diagnostics) thatpartner device has a mechanical or other failure. In exampleimplementations where partner device 315 is an insulin pump, an alertmay be triggered based on a pump fault such as an occlusion. Inembodiments, alerts may be triggered if partner device 315 has notdelivered insulin to a user or has not done so according to calculateddosages (e.g., based on analyte data).

In certain embodiments, each of the alerts is associated with one ormore actions that are to be performed in response to triggering of thealert. Alert actions may include, for example, activating an alarm via auser interface of analyte sensor system 308, such as displayinginformation on a display of analyte sensor system 308 or activating anaudible or vibratory alarm of analyte sensor system 308. In embodiments,alert actions include transmitting data to one or more display devices310 and/or partner device 315 such that the alert may be provided viauser interface 435 and/or 635 (with reference to FIGS. 4 and 5B). Forany alert action that is associated with a triggered alert, one or moredelivery options may define the content and/or format of the data to betransmitted, the device to which the data can be transmitted, when thedata can be transmitted, and/or a communication protocol that may beused for delivery of the data. For example, the propagation of alertsmay be prioritized to partner device 315. In embodiments, however, usersmay be inundated by alerts due to the number of connected devices thatmay be employed in connection with the gathering and use of analytedata. In such cases, it may be useful to coordinate alerts andnotifications across a user's devices, for example, in according to anescalation scheme that may be predefined, adaptable based on the networktopology, and/or based on user preferences.

In certain embodiments, multiple alert actions (each having respectivedelivery options) may be associated with a single alert such thatdisplayable sensor information or other alert information havingdifferent content and formatting, for example, can be transmitted torespective display devices 310 and/or partner devices 315 or otherdevices in response to triggering of a single alert. For example, amobile telephone may receive a data package including minimaldisplayable sensor information (that may be formatted specifically fordisplay on the mobile telephone), while a desktop computer may receive adata package including most (or all) of the displayable sensorinformation that is generated by the sensor electronics module ofanalyte sensor system 308 in response to triggering of a common alert.Advantageously, the sensor electronics module need not be tied to asingle display device 310, but rather can be configured to communicatewith a plurality of different display devices 310 directly,systematically, simultaneously (e.g., via broadcasting), regularly,periodically, randomly, on-demand, in response to a query, based onalerts or alarms, and/or the like.

In embodiments, analyte sensor system 308 is configured to provide oneor a plurality of different alarms directly and/or via transmission of adata package indicating an alarm should be initiated by one or aplurality of display devices 310 (e.g., sequentially and/orsimultaneously). In certain embodiments, analyte sensor system 308merely provides a data field indicating that an alarm condition exists,and display device 310, upon reading the data field indicating theexistence of the alarm condition, may decide to trigger an alarm. Insome embodiments, the sensor electronics module determines which of theone or more alarms to trigger based on one or more alerts that aretriggered. For example, when an alert trigger indicates severehypoglycemia, analyte sensor system 308 can perform multiple actions,such as activating an alarm on the sensor electronics module,transmitting a data package to a monitoring device indicating activationof an alarm on the display, and transmitting a data package as a textmessage to a care provider.

In embodiments, analyte sensor system 308 is configured to wait a timeperiod for the host to respond to a triggered alert (e.g., by pressingor selecting a snooze and/or off function and/or button on analytesensor system 308 and/or display device 310), after which additionalalerts can be triggered (e.g., in an escalating manner) until one ormore alerts are responded to. In embodiments, analyte sensor system canbe configured to send control signals (e.g., a stop signal) to partnerdevice 315 associated with an alarm condition (e.g., hypoglycemia), suchas an insulin pump, wherein the stop alert triggers a stop of insulindelivery via the pump. Although reference is made above to analytesensor system being configured to provide and/or trigger alerts, itshould be appreciated that display device 310 and/or partner device 315may additionally or alternatively provide and/or trigger alerts.

I. Connectivity Integration of Partner Devices

FIG. 8 depicts system 800 that, for example, may be used in connectionwith wireless analyte (e.g., glucose) monitoring, and in some instancesfor diabetes management, including for example the provision ofmedicaments. System 800 may involve various components interconnectedvia one or more wired and/or wireless connections for the communicationand exchange of information such as analyte data, medicament deliverydata, diabetes management feedback and related guidance and services,alerts/notifications, control signaling, and other information.

As illustrated by way of example in FIG. 8, embodiments of system 800include one or more of analyte sensor system 308; display devices 310 a,310 b, and/or 310 c; partner device 315; server systems 334 a and/or 334b; and services 805 that may be provided via server systems 334 a and/or334 b. Here it should be noted that in embodiments, server system 334 bmay be associated with partner device 315, and/or may be maintained by amanufacturer or provider of partner device 315, and server system 334 amay be associated with analyte sensor system 308, and/or may bemaintained by the manufacturer or provider of analyte sensor system 308.Additionally, and embodiments services 805 may be split into separateservices respectively supported, maintained, facilitated, and/orprovided by manufacturers/providers of an analyte sensor system 308, onthe one hand, and partner device 315, on the other hand. Thus, both oreither of server systems 334 a and 334 b may provide a gateway forreceiving services 805 (e.g., backend cloud services). For services 805supported on behalf of the manufacturer of partner device 315 only(e.g., in some cases, insulin pump related information, alerts,malfunction support, etc.), such services 805 may be provided via serversystem 334 b. For services 805 supported on behalf of the manufacturerof analyte sensor system 308 only (e.g., in some cases, providing theability for another individual/entity to monitor analyte data for a userof display device 310), such services 805 may be provided via serversystem 334 a in this example. In embodiments, services 805 may utilizeboth server systems 334 a and 334 b (e.g., in some cases, providing theability for another individual/entity to monitor analyte data andinsulin administration data for a user of display device 310 and partnerdevice 315). Additional aspects of remote services that may be providedvia cloud servers, for example server systems 334 a/334 b, are discussedbelow.

Certain of the foregoing components and features of the same shown inFIG. 8 have largely been described above with reference to, e.g., FIGS.1, 2A, 2B, 3A-C, 4, 5A, 5B, 6, and 7A-D. The components system 800 canbe interconnected by various links 802 a-d, 804 a-b, 806 a-b, 808 a-b,and 810, as shown in FIG. 8, where these links can each respectively beimplemented using communication media 305 for communication purposes. Itshould be appreciated that links 802 a-d, 804 a-b, 806 a-b, 808 a-b, and810 may be any type of communication link, including, for example,point-to-point, broadcast, multicast, etc. With respect to embodiments,it should be appreciated that like numbered elements shown in system 800may be implemented in that manners described above.

FIG. 9A depicts system 900 that, for example, may be used in connectionwith wireless analyte (e.g., glucose) monitoring, and in some instancesfor diabetes management, including for example the provision ofmedicaments. System 900 may involve various components interconnectedvia one or more wired and/or wireless connections for the communicationand exchange of information such as analyte data, medicament deliverydata, diabetes management feedback and related guidance and services,alerts/notifications, control signaling, and/or other information.Embodiments of system 900 include one or more of analyte sensor 308;display devices 910, including mobile phone 910 a, analyte displaydevice 910 b, and/or wearable device 910 c; partner devices 915, whichmay include medicament delivery device 915 a, first insulin pump 915 b,second insulin pump 915 c, and insulin pen 915 d; and/or display devices910′, which may include mirror 910 d, vehicle 910 e, and/or key fob 910f. In the example implementation shown in FIG. 9A, these components areconfigured to be part of personal area network (PAN) 902, and areinterconnected by links 906 a-j, 908, 916, and 918, as shown in FIG. 9A,where these links can each respectively be implemented usingcommunication media 305 for communication purposes. PAN 902 may employ aone or more of at least BLE, Wi-Fi, and the like.

System 900 may also include router 920 a coupled to one or more deviceswithin PAN 920 (e.g., to mirror 910 d via link 914), though not allpossible links are expressly shown. Router 920 a may in turn be coupledvia link 922 to server(s) 920(b) (e.g., server system 334, withreference to FIG. 2A), which may in turn be coupled via link 924 to cellnetwork 920 c (e.g., a 4G LTE network or the like). Cell network 920 cmay also be coupled via link 926 to cellular-enabled devices within PAN902, such as mobile phone 910 a. In embodiments, any of the devicesshown in FIG. 9A may be cellular-enabled and thus couplable directly tocell network 920 c and/or WAN 904 or elements thereof. For example,analyte sensor system 308 may be equipped with a cellular or otherlonger range radio component and may thus be couplable directly to cellnetwork 920 c and/or WAN 904 or elements thereof. As shown in FIG. 9A,router 920 a, server(s) 920 b, and cell network 920 c may be configuredto be part of wide area network (WAN) 904. Links 914, 922, 924, and 926may be implemented using communication media 305 (e.g., may be wired orwireless, etc.). WAN 904 may generally provide cloud services to one ormore devices in PAN 902. Again not all possible links between thedevices in WAN 904 and the devices in PAN 902 are expressly shown, butthey will be appreciated by one of skill in the art upon studying thepresent disclosure. It should also be appreciated that in some cases,elements of WAN 904 may be incorporated into PAN 902 and vice versa.

A number of the foregoing components of system 900 and features of thesame have been described above with reference to at least, e.g., FIGS.1, 2A, 2B, 3A-C, 4, 5A, 5B, 6, and 7A-C. One of skill in the art uponstudying the present disclosure will recognize where and how the abovedescriptions of these components may be applicable here, whether or notthe same is expressly conveyed herein.

With regard to system 900, where system 900 includes partner devices915, two examples may drive the particular arrangement and/orimplementation of the above-listed components of system 900 for wirelessanalyte monitoring and/or diabetes management. The first example doesnot involve medicament (e.g., insulin) delivery by partner devices 915(e.g., by medicament delivery device 915 a). Under this example, inembodiments, system 900 includes analyte sensor system 308, one or moredisplay devices 910, 910′ that are given authority to sendcommand/control signals to analyte sensor system 308 (e.g., mobile phone910 a and/or analyte display 910 b), as well as one or more displaydevices 910, 910′ that are configured to be in a display only state(e.g., wearable device 910 c and/or key fob 910 f). In embodiments, thisexample involves display devices 910 a and 910 b operating in acommand/control state (e.g., smartphone 120 or the like and analytedisplay device 110, referencing FIG. 1), and one or more display devices910, 910′ operating in a display only state (e.g., key fob 910 f andsmart mirror 910 d or wearable device 910 c, etc.).

The second example, unlike the first example, does involve medicament(e.g., insulin) delivery by at least one of partner devices 915 (e.g.,medicament delivery device 915 a). The medicament delivery by medicamentdelivery device 915 in this example may or may not be automated (e.g.,an automated insulin pump or non-automated insulin pen). In this secondexample, where medicament delivery device 915 a that deliversmedicaments is part of system 900, interoperability issues may beintroduced regarding which device (e.g., medicament delivery device 915,analyte sensor system 308, and/or display devices 910, 910′) maycontrol/manage the generation of analyte data, including for example thecalculation of CGM values and the like.

With respect to this second example, in order to flexibly and adaptivelysupport potentially varying and a priori unknown system requirements 650(referencing FIG. 5B for example) of various partner devices 915 from aninteroperability standpoint, where such partner devices 915 may beprovided by various manufacturers/developers different from themanufacturers/developers of other components of system 900 (e.g.,display devices 910, 910′ and/or analyte sensor system 308, etc.), insome cases medicament delivery device 915 a (or like partner devices915) should be able to control the exchange of data between analytesensor system 308 and display devices 910, 910′ via links 906 a-g. Suchcontrol may be provided, for example, by a user of display devices 910,910 (e.g., a user of phone 910 a, where authority for the control isgiven using mobile phone 910 a to medicament delivery device 915 vialink 916).

In embodiments, aspects of communication sessions and/or sensor sessionsshould also be controlled (e.g., partner devices 915, analyte sensorsystem 308, and/or display devices 910, 910′ should in some cases beable to limit command/control signaling, including where such signalingis related to analyte data). For example, if medicament delivery device915 a is used for insulin delivery, the transmission of commandsignaling to analyte sensor system 308 may be restricted to only certaindevices within system 900. Certain partner devices 915 may in some casesbe generally less robust, for example, in terms of maintaining accuracyin a relatively high interference environment. In such cases, forexample due to system requirements 650 of medicament delivery device 915a, the probability of medicament delivery device 915 a receiving analytedata from analyte sensor system 308 inaccurately may be reduced wheredisplay devices 910, 910′ are restricted from sending control/commandsignaling related to, e.g., starting, stopping, or calibrating of asensor session. For example, such signaling may result in analyte sensorsystem 308 operating in a fashion that is not compatible or optimal orpreferred with respect to medicament delivery 915 a, as may be reflectedfor example by system requirements 650 thereof. In embodiments, it maybe beneficial to delegate authority to send control/command signals toonly particular devices within system 900 based on the device typeand/or based on an operation mode of system 900. In embodiments, it maybe beneficial to flexibly add or remove devices (e.g., partner devices915 and/or display devices 910, 910′) to/from system 900, whether in PAN902 or WAN 904, to manage the access of such devices to analyte sensorsystem 308, and/or to manage how alerts propagate across various suchdevices and other devices within system 900.

In embodiments, it may also be beneficial to system 900 (including,e.g., for medicament delivery device 915 a) to provide a means forcontrolling alert settings, for safety and/or robustness purposes. Inembodiments, if certain links become unavailable (e.g., link 906 dbetween analyte sensor system 308 and medicament delivery device 915 a,link 922 between mobile phone 910 a and cell network 920 c, etc.),whether literally or due to system constraints such as power etc.,and/or depending on other network conditions/configurations of PAN 902and/or WAN 904 that will be discussed herein, it may be beneficial toadaptively modify aspects of system 900. Additionally, in some cases, itis beneficial to authenticate partner devices 915 attempting toestablish a connection with analyte sensor system 308 and/or preventunauthorized partner devices 915 from accessing analyte sensor system308.

Accordingly, embodiments of the present disclosure provide a moreflexible/adaptable system of analyte sensor system 308, display devices910, 910′ and/or partner devices 915, as well as methods of using thesame, where such flexibility/adaptability may including setting ormodifying configuration parameters 520 of analyte sensor system 308,alerts/alarms that may propagate through system 900, control/commandcapabilities of display devices 910, 910′ and/or partner devices 915,connection models employed among devices in system 900, and so forth. Inembodiments, the flexibility/adaptability is facilitated at least inpart using diabetes management partner interface (DMPI) 750 that may beimplemented using analyte sensor system 308. As will be described infurther detail, in embodiments, various devices within system 900,including for example partner devices 915, can utilize DMPI 750 toaccess/modify configuration parameters 520 of analyte sensor system 308and (re)configure aspects thereof and/or aspects of, e.g., displaydevices 910, 910′, for operation in accordance with system requirements650 of partner device 915 (e.g., medicament delivery device 915 a). Forexample, system requirements 650 may be driven or based on safety and/orregulatory requirements applicable to medicament delivery device 915 a,user experience configurations/settings/constraints, power consumptionspecifications/constraints, etc. System requirements 650 may be used todetermine the format of data packages transmitted to partner devices 915and/or display devices 910, 910′ the display devices, as well as theprotocol used for transmitting such data packages, based on therespective preferences/specifications/etc. of partner devices 915 and/ordisplay devices 910, 910′.

With further reference to FIG. 9A, example embodiments involving variouspartner devices 915 within system 900 will now be described. In thebelow-described example implementations, system 900 may involve threepartner devices 915, namely, first insulin pump 915 b, second insulinpump 915 c, and insulin pen 915 d. Generally, these three partnerdevices 915 may each have different capabilities and performancecharacteristics, which may be reflected in certain respective systemrequirements 650 (referencing FIG. 5B) of the three partner devices 915,and each of the three partner devices 915 may use DMPI 750 (referencingFIG. 10A by way of example) of analyte sensor system 308 to modifyconfiguration parameters 520 of analyte sensor system 308 in accordancewith respective system requirements 650. In this manner, analyte sensor308 may be adapted for better interoperability with any one of the firstand second insulin pumps and the insulin pen, whichever partner device915 is connecting to analyte sensor system 308 and/or within system 900.It will be appreciated upon studying the present disclosure that thisdescription of first insulin pump 915 b, second insulin pump 915 c, andinsulin pen 915 d can apply equally to any examples of partner devices915, including medicament delivery device 915 a and similar devices.

For illustrative purposes, more detail will now be provided with respectto the respective characteristics of first and second insulin pumps 915b, 915 c and insulin pen 915 d in these example implementations. By wayof example, first insulin pump 915 b may have a relatively robustalgorithm for administration of medicaments, may have a bigger (orhigher capacity) battery or power supply, and may require blood glucosecalibrations to occur every 12 hours. First insulin pump 915 b'srelatively robust algorithm may essentially mean that the algorithm maybe relatively less susceptible to interference from other devices thatmay attempt to connect to analyte sensor system 308, such as displaydevices 910, 910′, including where such interference may involveinterference during connection establishment or interference withsending command signaling to analyte sensor system 308. For example, thealgorithm of first insulin pump 915 b may be able to operate betteracross a larger range of configuration parameters 520, and may be ableto better handle calibrations and start/stop events initiated by otherdevices. The 12 hour blood glucose calibration requirement may reflectaccuracy constraints of the first insulin pump (and, e.g., can bereflected in system requirements 650 of first insulin pump 915 b).

By way of further example, second insulin pump 915 c may have arelatively less robust algorithm used in the administration ofmedicaments, may be less constrained in terms of blood glucose accuracycalibrations (e.g., may be able to use a factory calibration accuracylevel), and may support remote services provided by server 920 b (e.g.,via a connection/link to server 920 b directly through cell network 920c (which link is not shown in FIG. 9A), indirectly through router 920 a(which link is also not shown), or indirectly for example through mobilephone 910 a). Second insulin pump 915 c's relatively less robustalgorithm may essentially mean that second insulin pump 915 c was notdesigned to operate well in a high interference environment, where otherdevices within system 900 may be competing to establish connections withanalyte sensor system 308 and/or may be sending command/controlsignaling thereto.

Continuing the illustrative example, insulin pen 915 d may havehard/soft keys to receive user input, and may include a simple userinterface, both of which can be represented for example by userinterface 635 (referencing FIG. 5B). Insulin pen 915 d may further beadapted to query and share data with analyte sensor system 308, forexample to read analyte data therefrom and share insulin relatedinformation (e.g., related to dosage) therewith.

Given the above example information regarding first and second insulinpumps 915 b, 915 c and insulin pen 915 d, example scenarios of how DMPI750 may be used to flexibly adapt system 900 will now be provided. Afirst example scenario may involve the use of first insulin pump 915 bwith analyte sensor 308. Once first insulin pump 915 b and analytesensor system 308 are configured for use (e.g., applied to the user,powered on, etc.), the user's authorization for first insulin pump 915 bto take control of analyte sensor system 308 and begin administeredmedicaments to the user may be requested. For example, such request maybe provided to the user via user interface 435 of mobile phone 910 a(referencing FIG. 4) that may be connected to analyte sensor system 308and/or the first insulin pump, via user interface 635 of first insulinpump 915 b (referencing FIG. 5B), and/or via a user interface of analytesensor system 308. If the user authorizes the request, first insulinpump 915 b may use DMPI 750 to access and set and/or modifyconfiguration parameters 520 of analyte sensor system 308, in accordancewith system requirements 650 of first insulin pump 915 b (e.g.,referencing FIG. 10A).

In this example, in terms of first insulin pump 915 b accessingconfiguration parameters 520 via DMPI 750, the developer of firstinsulin pump 915 b may have already integrated and tested pump 915 bwith analyte sensor system 308 prior to the products being sold orprovided to the user. In this manner, first insulin pump 915 b mayinclude instructions, code, or other files in storage 615 that enablefirst insulin pump 915 b to properly navigate DMPI 750 and configurationparameters 520. In embodiments, such instructions may be obtained byfirst insulin pump 915 b by downloading and/or installing a softwaredesign kit associated with analyte sensor system 308. For example,insulin pump 915 b may obtain such instructions or other informationfrom server 920 b and/or WAN 904 or elements thereof.

By way of example, first insulin pump 915 b may use DMPI 750 to changeone or more wireless connectivity parameters of configuration parameters520. The wireless connectivity parameters may include settings relatedto a database that includes/stores information related to accessibilityof devices (e.g., a whitelist) maintained by analyte sensor system 308,and first insulin pump 915 b may change such whitelist settings, forexample, such that first insulin pump 915 b may not age off thewhitelist until a battery level of first insulin pump 915 b falls belowa particular threshold (e.g., 5%). First insulin pump 915 b may set thewireless connectivity parameters in this manner because, as mentionedabove, first insulin pen 915 b has a larger battery (e.g., higherbattery capacity), and for example if for some reason first insulin pump915 b is disconnected from analyte sensor system 308 (e.g., by going outof range), then it may be beneficial for first insulin pump 915 b toseek to re-establish connection with analyte sensor system 308 as soonas the opportunity arises.

First insulin pump 915 b may use DMPI 750 to set or change additionalwireless connectivity parameters, such as a timeout setting for thetransmission of advertisement messages, for example so that analytesensor system 308 advertises for a total of 1 second before ceasing thetransmission of advertisement messages. That is, in this example,advertisement duration 614 (referencing FIG. 6) may be set to 1 second.First insulin pump 915 b may set the wireless connectivity parameters inthis manner because first insulin pump 915 b may have a relativelyaccurate scanning algorithm (e.g., as may have been determined bydevelopers of first insulin pump 915 b or by other means), such thatfirst insulin pump 915 b may be able to reliably establish a connectionwith analyte sensor system 308 when appropriate (e.g., once everyadvertisement window interval 612, which may be 5 minutes in some cases)without advertising for a longer duration. By shortening advertisementwindow interval 612, battery power may be saved.

Furthermore, first insulin pump 915 b may use DMPI 750 to change one ormore access control parameters of configuration parameters 520. Theaccess control parameters may include, for example, a number of displaydevices 910, 910′ that analyte sensor system 308 can maintain aconnection with, and/or may include, for example, a level of access orcontrol such display devices 910, 910′ may have with respect to analytesensor system 308. By way of illustration, first insulin pump 915 b mayset either or both of these access control parameters such that thereare no restrictions imposed. First insulin pump 915 b may set the accesscontrol parameters in this manner because, as mentioned above, firstinsulin pump 915 b may have a relatively robust algorithm for insulinadministration, and therefore may not need to prevent other devices fromsending calibrations etc. (e.g., because first insulin pump 915 b'salgorithm may be able to handle such outside events and adjust to themaccordingly).

Additionally, first insulin pump 915 b in this example may use DMPI 750to change one or more analyte data parameters of configurationparameters 520. The analyte data parameters may include a calibrationperiod for analyte sensor system 308. For example, first insulin pump915 b may set the calibration period to 12 hours, per theabove-mentioned system requirement 650 of first insulin pump 915 b.

A second example scenario may involve the use of second insulin pump 915c with analyte sensor 308. Similar to the above example involving firstinsulin pump 915 b, after set up and authorization, second insulin pump915 c may use DMPI 750 to access and set and/or modify configurationparameters 520 of analyte sensor system 308, in accordance with systemrequirements 650 of second insulin pump 915 c (e.g., referencing FIG.10A). Similar to the previous example, in terms of second insulin pump915 c accessing configuration parameters 520 via DMPI 750, the developerof second insulin pump 915 c may have already integrated and tested thepump with analyte sensor system 308 prior to the products being sold orprovided to the user. In this manner, second insulin pump 915 c may beadapted to properly navigate DMPI 750 and configuration parameters 520.In embodiments, second insulin pump may also reconfigure DMPI 750 beforeaccessing configuration parameters 520.

With respect to the second example scenario, several situations arecontemplated here. In a first situation, where, as an initial matterwhen deciding to employ an insulin delivery device, the user selectssecond insulin pump 915 c instead of first insulin pump 915 b or insulinpen 915 d. In a second situation, the user may have already been usingfirst insulin pump 915 b or insulin pen 915 d for a time but then mayswitch to second insulin pump 915 c. That is, while first and secondinsulin pumps 915 b and 915 c and/or insulin pen 915 d are notnecessarily used simultaneously, this example encompasses first andsecond insulin pumps 915 b and 915 c and/or insulin pen 915 d being usedin a serial fashion (e.g., user decides to use different pump product,or the first pump product breaks, etc.) It should also be appreciatedthat any partner devices 915 may be used in a serial fashion.

By way of example, second insulin pump 915 c may use DMPI 750 to set orchange wireless connectivity parameters of analyte sensor system 308,including the timeout setting for the transmission of advertisementmessages, for example so that analyte sensor system 308 may advertisesfor a total of 5 seconds before ceasing the transmission ofadvertisement messages. Second insulin pump 915 c may set the wirelessconnectivity parameters in this manner because second insulin pump 915 cmay have a relatively less accurate scanning algorithm (e.g., as mayhave been determined by developers of second insulin pump 915 c or byother means), such that second insulin pump 915 c may not be able to asreliably establish a connection with analyte sensor system 308 whenappropriate (e.g., once every advertisement window interval 612, whichmay be 5 minutes in some cases) without advertising for a relativelylonger duration.

Additionally, second insulin pump 915 c in this example may use DMPI 750to change additional wireless connectivity parameters. Such wirelessconnectivity parameters may be related to the use of remote (e.g.,cloud-based) services that for example may be provided by server 920 b(e.g., services 805 with reference to FIG. 8). By way of illustration,second insulin pump 915 c may set the wireless connectivity parametersto enable the use of such remote services (e.g., a cloud-based supportmodule), and to configure analyte sensor system 308 to transmit diabetesmanagement feedback received in connection with such remote services todisplay devices 910, 910′ that may be within range of and/or connectingto analyte sensor system 308 (e.g., where in some cases display devices910, 910′ may be in a display only state/mode). Second insulin pump 915c may set these wireless connectivity parameters in this fashion becausesecond insulin pump 915 c may have been approved to propagate suchdiabetes management feedback to other display devices 910, 910′, etc.Furthermore, second insulin pump 915 c may set these wirelessconnectivity parameters such that if the remote services becomeunavailable (e.g., by loss of a link, such as for example links 914,922, 924, or 926, or the like, to server 920 b), then the diabetesmanagement feedback feature may be disabled and a related notificationto display devices 910, 910′ etc. that may be within range of and/orconnecting to analyte sensor system 308.

Furthermore, second insulin pump 915 c may use DMPI 750 to change one ormore access control parameters of configuration parameters 520,including for example by setting the number of display devices 910, 910′that analyte sensor system 308 can connect to three devices, and bysetting the level of access or control of such display devices 910, 910′with respect to analyte sensor system 308 such that the up to threedisplay devices 910, 910′ operate in a display only state or modewherein such display devices 910, 910′ may be able to display analyteand/or insulin delivery data, related notifications/alarms, and otherinformation, but are without the ability to send control/commandsignaling to analyte sensor 308. Second insulin pump 915 c may set theaccess control parameters in this manner because, as mentioned above,second insulin pump 915 c may have a relatively less robust algorithmfor insulin administration, and therefore may seek to prevent otherdevices from sending calibrations etc. (e.g., because second insulinpump 915 c's algorithm may not be able to handle such outside events oradjust to them accordingly).

Moreover, with respect to the analyte data parameters that may beincluded in configuration parameters 520, second insulin pump 915 c maynot make any changes to the factory calibration parameters (e.g.,including the factory calibration period) that may be default foranalyte sensor system 308 as provided off the shelf or by themanufacturer thereof. This may be because, as mentioned above, secondinsulin pump 915 c can use a factory calibration accuracy level. In thissituation, analyte sensor system 308 may not generate calibrationprompts, and can simply follow the default calibration schedule.

A third example scenario may involve the use of insulin pen 915 d withanalyte sensor system 308. Similar to the above example involving firstand second insulin pumps 915 b, 915 c, after set up and authorization ofinsulin pen 915 d for use, including for multiple daily injections ofinsulin that may be made manually, insulin pen 915 d may use DMPI 750 toaccess and set and/or modify configuration parameters 520 of analytesensor system 308, in accordance with system requirements 650 of insulinpen 915 d (e.g., referencing FIG. 10A). Similar to the previousexamples, in terms of insulin pen 915 d accessing configurationparameters 520 via DMPI 750, the developer of insulin pen 915 d may havealready integrated and tested the pen with analyte sensor system 308prior to the products being sold or provided to the user. In thismanner, insulin pen 915 d may be adapted to properly navigate DMPI 750and configuration parameters 520.

By way of example, insulin pen 915 d may use DMPI 750 to change one ormore access control parameters of configuration parameters 520,including for example making a selection to establish a directconnection with analyte sensor system 308, as opposed to establishing aconnection to analyte sensor system 308 indirectly, e.g., via mobilephone 910 a. Notwithstanding this selection, mobile phone 910 a maystill establish connections with analyte sensor system 308 and/orinsulin pen 915 d and exchange information therewith, subject to howconfiguration parameters 520 may otherwise be set.

Insulin pen 915 d may also use DMPI 750 to change wireless connectivityparameters for analyte sensor system 308, including with respect to thetransmission of advertisement messages, for example so that analytesensor system 308 can advertise according to default settings fordisplay devices 910, 910′, etc., but with respect to insulin pen 915 danalyte sensor system 308 can advertise using an extended advertisementduration 614 and/or an decreased advertisement window interval 612(referencing FIG. 6). Insulin pen 615 d may set the wirelessconnectivity parameters in this manner because for devices such asinsulin pen 615 d, users may need a more responsive system that forexample has access to up to date glucose data readily available to theuser.

Additionally, insulin pen 615 d may use DMPI 750 to access analyte dataparameters of configuration parameters 520 to enable the use of a boluscalculator that may be implemented, for example, by analyte sensorsystem 308. For example, DMPI 750 may provide insulin pen 915 d withaccess to bolus calculation parameters that may be maintained by analytesensor system 308, such that analyte sensor system 308 can modify thebolus calculation parameters. In embodiments of the present disclosure,analyte sensor system 308 may use the bolus calculation parameters toprovide a bolus-related recommendation to the user, where therecommendation is based on a calculation performed by analyte sensorsystem 308 using the bolus calculation parameters (e.g., and a boluscalculator of analyte sensor system 308).

Insulin pen 915 d in this example may also use DMPI 750 to change one ormore additional analyte data parameters of configuration parameters 520.For example, insulin pen 915 d may set the calibration period to 12hours, in some cases for reasons similar to those discussed above withrespect to system requirement 650 of first insulin pump 915 b.

With further regard to example scenario involving insulin pen 915 d, insome cases, the user may want and/or need to administer insulin, and mayaccordingly select a bolus value on insulin pen 915 d (e.g., using userinterface 635, with reference to FIG. 6). A connection may then beestablished between insulin pen 915 d and analyte sensor system 308,such that insulin pen 915 d may send the user's selected bolus valuethereto. If the user's blood glucose level is declining more than ispreferable/normal, and/or if the user already has a substantial amountof insulin on board, then analyte sensor system 308 can use theabove-mentioned bolus calculator to make a bolus-related recommendationto the user and/or a safety decision. Analyte sensor system 308 may inthis situation send a notification or alert to the user regarding theamount of insulin selected by the user (e.g., that the selected bolusvalue is too high). In such cases, analyte sensor system 308 can attemptto prevent the user from injecting the selected bolus value. Forexample, there may be a mechanical prevention feature on insulin pen 915d that prevents the user from injecting a bolus that exceeds the bolusvalue calculated by analyte sensor system 308. Such a mechanicalprevention feature may be implemented, for example, by disabling(retracting) medicament delivery mechanism 640 (e.g., a needle) and/orpreventing an overly large bolus from being moved into an injectionreservoir of the insulin pen. Signaling from analyte sensor system 308may trigger the mechanical prevention feature, for example.

As will be described below, additional configuration parameters 520and/or system requirements 650 may be present in embodiments of system900, and one of ordinary skill in the art will appreciate upon studyingthe present disclosure additional aspects of using configurationparameters 520 and/or system requirements 650 in the context of theabove example scenarios as well as in other contexts expressly orimplicitly described or alluded to herein. It should be appreciated thatthe above example scenarios and features thereof are not necessarilyrequired in all embodiments of the present disclosure, and with respectto embodiments may disclosed features by way of illustration only.

Given the general context of the above example scenarios, additionaldetails regarding configuration parameters 520 and system requirements650 will now be described with reference to FIG. 10A. For example, asshown in FIG. 10A, within system 1000, partner device 315 may includesystem requirements 650 associated therewith that should be met in orderto support functionality according to pre-determined expectations,design constraints, system specifications, and/or the like. In order tosupport system requirements 650, partner device 315 may use DMPI 750 ofanalyte sensor system 308 to access configuration parameters 520 (e.g.,of analyte sensor system 308). Configuration parameters 520 can serve asflexible settings that may be adapted, varied, programmed, set, and/ormodified by partner device 315 using DMPI 750 such that communicationsbetween/among analyte sensor system 308, partner device 315, and/ordisplay device 310 allow system requirements 650 to be met.

By way of example, configuration parameters 520 may include wirelessconnectivity parameters, access control parameters, power managementparameters, and/or analyte data parameters. The wireless connectivityparameters may generally relate to wireless connectivity andcommunications within system 900 (referencing FIG. 9A, and/or system 800referencing FIG. 8, etc.), and the handling of wireless communicationsand connectivity with analyte sensor system 308, including with and/orby one or more of display device 310 and partner device 315, as well asother connections that are described herein (e.g., between displaydevice and partner device 315).

The wireless connectivity parameters may relate to aspects of awhitelist that may be maintained by analyte sensor system 308. Forexample, the wireless connectivity parameters may relate to age-offsettings by specific devices or groups of devices. For example, wherepartner device 315 is an insulin pump that dies, a default age-off timemay be used as a backup mechanism to halt the use of the insulin pump incase the user does not realize the pump has died, though the age-off inthis scenario may be subject to user override in the event that the userapproves not aging off the pump. In example implementations, the pumpmay have a known lifespan, and the age-off time may be set toaccommodate this. For example, the known lifespan may be battery-drivenand/or the pump may need to be replaced/serviced after a known amount oftime, which may be reflected in system requirements 650, and the pumpmay set its age off time accordingly by modifying configurationparameters 520 using DMPI 750. This age off time may be adjusted on thefly, for example, if problems arise sooner than expected, or if due tointervening circumstances the expected issues are pushed out in time(e.g., due to efficient power management or less power-hungry use thanexpected). Additionally, partner device 315 may be able to use DMPI 750to modify whitelist settings in order to force certain devices to ageoff the whitelist such that battery budget may be saved vis-à-visanalyte sensor system 308 and/or partner device 315.

In embodiments, the wireless connectivity parameters may relate to ahierarchy/prioritization of connection ordering among connectabledevices (e.g., by types of devices, by particular devices, etc.). Thewireless connectivity parameters may relate which devices or types ofdevices may be whitelisted (e.g., partner devices 315 vs. displaydevices 310, and including particular devices). In embodiments, thewireless connectivity parameters may relate to connection modes (as willbe described in further detail elsewhere herein) to be employed forcertain devices or under certain conditions; and/or to networkconfiguration settings, e.g., to provide fallback configurations and/orroutines in case certain connections, such as cloud, cellular, orpersonal area network connections, are not available, etc.

In embodiments, the wireless connectivity parameters may include acondition under which partner device 315 is to be removed from awhitelist maintained by analyte sensor system 308. The condition may beset/modified such that partner device 315 is to be removed from thewhitelist when a battery level of partner device 315 meets or crosses athreshold. For example, if the battery level of partner device 315 dropssuch that the use of partner device 315 may not be sustainable for muchmore time (e.g., less than 10%), partner device 315 may be removed fromthe whitelist, and the user may be notified that the user should notrely on partner device 315 going forward (e.g., for the delivery ofmedicaments etc.).

For example, the wireless connectivity parameters may include wirelessconnection settings, such as settings related to advertising timeouts,structure, and/or protocols. With reference to FIG. 6, in embodiments,the wireless connectivity parameters may be used to set/modifyadvertisement structure 622, advertisement duration 614, advertisementwindow interval 612, and/or advertisement period 616. In some cases, thewireless connectivity parameters may relate to settings in server system334 and/or the user of services provided via server system 334.

The power management parameters that may be included in configurationparameters 520 may be used to implement battery budget control, forexample. In some cases, configuration parameters 520 related to powermanagement may be implemented based on system requirements 650 ofpartner device 915, as well as power management concerns regardinganalyte sensor system 308 and/or display devices 910, 910′. For example,even if system requirements 650 indicate that a particular partnerdevice 915 would be power-hungry, a decision may still be made as towhether such a partner device 915 should be allowed to consume the powerthat would satisfy system requirements 650. Accordingly, embodiments ofthe present disclosure involve controlling how the battery budget isallocated between/among analyte sensor system 308, partner devices 915,and/or display devices 910, 910′. For example, thresholds may be set, insome cases on per-device basis, such that if it is determined thatproposed settings for power management parameters would cause suchthresholds to be met, user approval may be requested before suchproposed settings are implemented vis-à-vis configuration parameters520.

In embodiments where system requirements 650 may create power managementimplications for analyte sensor system 308, configuration parameters520, including in some cases parameters other than power managementparameters may be set/modified in order to effect a trade-off betweendata reliability and battery life of analyte sensor system 308. Forexample, certain wireless connectivity parameters, e.g., as discussedabove, may be set to age off particular display devices 910, 910′ inresponse to power management implications created by system requirements650. In additional examples, aspects of advertisement structure 622(e.g., with reference to FIG. 6) may be modified via settings/modifyingconfiguration parameters 520 in order to manage power consumption. Inyet further examples, connection models and/or operating modes may bechanged in order to manage power consumption, and such changes may beeffected via settings/modifying configuration parameters 520. In somecases, the trade-off between data reliability and battery life may bedetermined using a slide bar provided by user interface 435 (for examplereferencing FIG. 4) and/or running on analyte sensor application 425 aand/or partner device application 425 b. In embodiments, the trade-offmay be implemented through an automatic adjustment to configurationparameters 520. For example, a low battery mode may be implemented usinga predetermined set of values for configuration parameters 520. Such amode may be entered automatically or manually or semi-manually with someuser intervention.

The analyte data parameters that may be included in configurationparameters 520 may include, for example, algorithm settings for analytesensor system 308 (e.g., calibration schedule/settings, CGMstart/stop/calibrate access, factory calibration settings, etc.),alert/alarm/notification settings (e.g., to set which display device310/partner device 315 receives which alerts, which display device310/partner device 315 can acknowledge or respond to which alerts, ifspecial alerts are enabled for particular partner devices, the orderingfor sending/escalating alerts, the types of alerts to send under certainconditions, etc.). The analyte data parameters may include accuracyparameters and/or calibration parameters for analyte sensor system 308.For example, the calibration parameters may include a calibration periodfor analyte sensor system 308. The calibration period may be modified orset in accordance with system requirements 650 of partner device 315regarding required accuracy levels of analyte or CGM data. For example,partner devices 315 from different manufacturers may have differentaccuracy requirements and may thus impose different demands oncalibrations. The analyte data parameters may also include a factorycalibration code that can be used to set or modify the calibrationperiod (e.g., in some cases to set the calibration period to zero). Inexample embodiments, the analyte data parameters include boluscalculation parameters that may be used to perform calculations andprovide bolus recommendations based on the calculations. In exampleembodiments, the analyte data parameters may concern the types ofanalyte information that can be read/sent, including for exampleexpected glucose value (EGV), rate, state, predicted EGV, errors, andthe like.

The access control parameters that may be included in configurationparameters 520 may include one or more of a number of display devices310 and/or partner devices 315 connectable to analyte sensor system 308,and a level of access or control analyte sensor system 308 may give toone or more of display devices 310 and/or partner devices 315 in termsof sending command and/or control signaling to analyte sensor system 308where the command/control signaling relates to analyte data. In somecases, before being granted, the level of access or control may need tobe approved by a user (e.g., via analyte sensor application 425 a and/orpartner device application 425 b, with reference to FIG. 4). Differenttypes of display devices 310 and/or partner devices 315 may be granteddifferent levels of access or control. In embodiments the access controlparameters may include security and/or privacy related parameters. Forexample such security/privacy parameters may involve encryption keysthat may be used for exchanging information with partner devices 315. Insome cases, analyte sensor application 425 a and partner deviceapplication 425 b and/or medicament delivery application 625 maygenerate public and private keys where the public keys are shared andthe private keys are used to encrypt data exchange among theapplications. In some cases, such keys may be stored remotely, forexample in server 920 b. Additional security/privacy features mayinvolve identity resolution and/or tracking prevention.

By way of example, referencing FIG. 9A, in some cases, if a user wantsto add a display device 910, 910′ or a partner device 915 to system 900,mobile phone 910 (or another display device 910, 910′) may notify theuser regarding changes that may result to the user's piconet structure(e.g., in terms of how command/control commands may be used, how alertsand alarms may change, etc.). This may be done using a known mapping ofhow system requirements 650 of partner device 915 may implymodifications to configuration parameters 520. In some cases, theaddition of display devices 910, 910′ or partner devices 915 to system900 may be subject to an approval procedure implemented by a specificpartner device 915, for example so that partner devices 915 can confirmthat system requirements 650 will still be met with the addition of thedevice. Regarding the addition of partner and/or display devices 915,910, 910′, the user may provide authorization ahead of time for specificdevices using application 425 b.

In embodiments, configuration parameters 520 may be adaptedautomatically in response to changes relating to system 900. By way ofexample, medicament delivery devices 915 a or other partner device 915may become unavailable, in which case configuration parameters 520 maybe modified and/or may be restored to a prior state. Additionally,configuration parameters 520 may be adapted in response to system 900entering into a particular operating mode, as described below. Forinstance, in the hybrid operating mode, configuration parameters 520 maybe modified so that medicament delivery device 915 a may be configuredto use the continuous connection model. Configuration parameters 520 maybe adapted according to a projected battery life of medicament deliverydevice 915 a, for example to change the connection model used to connectanalyte sensor system 308 and medicament delivery device 915 a in orderto save battery. In embodiments, configuration parameters 520 may bemodified adaptively based on time of day, location, or radio conditions.The user may delegate certain controls to any devices within system 900.For example, the user may authorize medicament delivery device 915 a toact as a system administrator of sorts, such that medicament deliverydevice 915 a handles the addition/removal of display devices 910, 910′,connection models and operating modes, management of alerts,authentication/encryption processes, etc. Once authorized by the user,processes may be managed and permissions granted as need, for exampleusing a system of registration and subscription or various services orcharacteristics (e.g., that may be supported in BLE).

Additionally, in embodiments, as display devices 910, 910′ areadded/removed from system 900, there may be implications on systemrequirements 650 of partner devices 915 that trigger modifications toconfiguration parameters 520 or other aspects of system 900. Forexample, system requirements 650 may impose a limit on the number ofdisplay devices 910, 910′ that may be connectable to analyte sensorsystem 308. If that limit is implicated by the addition of displaydevices 910, 910′, certain other display devices 910, 910′ may beremoved to maintain operation in accordance with system requirements950. The removal may occur following a pre-determined hierarchy ofdisplay devices 910, 910′ that should be removed if the limit isimplicated, or may be based on removing a particular display device 910if similar display devices 910, 910′ are connectable (e.g., removing auser's PC if the user's tablet is also connectable).

Configuration parameters 520 may also accommodate specific scenariosthat may be encountered in connection with the use of medicamentdelivery device 915 a in system 900. One such scenario involves theexchange of medicament deliver device 915 a for a new medicamentdelivery device 915 a (e.g., as described below in connection withoperating modes). For example, medicament delivery device 915 a maybecome old or otherwise subject to disposal. In example implementations,medicament delivery device 915 a may be disposable, e.g., may bedesigned to have a known usable life, after which medicament deliverydevice 915 a should be replaced in its entirety. By way of illustration,where medicament delivery device 915 a is an insulin pump, a pumpsession may end after 3 days, at which time the pump may need to bereplaced, in whole or in part (e.g., in some cases, just medicamentdelivery mechanism 640 may need to be replaced, referencing FIG. 5B). Inembodiments, analyte sensor system 308 may likewise need to be replacedperiodically, in whole or in part (e.g., in some cases, just continuousanalyte sensor 10 may need to be replaced, referencing FIG. 1), and thereplacement period may differ from the that of medicament deliverydevice 915 a. For example, the replacement period for analyte sensorsystem 308 may be 7 days.

The difference in replacement periods as between medicament deliverydevice 915 a and analyte sensor system 308 may result in a situation inwhich a sensor session for analyte sensor system 308 to collect andgenerate analyte data is expiring while the pump session for medicamentdelivery device 915 a is ongoing. This can potentially create medicalcomplication for the user of analyte sensor system 308 and medicamentdelivery device 915 a, because the user may need to replace at least acomponent of analyte sensor system 308, but medicament delivery device915 a may require continuous, substantially continuous, or at leastsomewhat regular reception of analyte data generated using analytesensor system 308. Changing at least a component of analyte sensorsystem 308 (e.g., sensor 10), can disrupt the at least somewhat regularreception of analyte data that may be required/expected by medicamentdelivery device 915 a.

Accordingly, embodiments of the present disclosure involve using DMPI750 to facilitate relatively undisrupted operation of medicamentdelivery device 915 a through periodic device/component replacementsthat may occur with respect to analyte sensor system 308 and/ormedicament delivery device 915 a. In embodiments, this may involveanalyte sensor system 308 indicating to a user thereof when themedicament delivery session of medicament delivery device 915 a and/orthe sensor session of analyte sensor system 308 is expected to end(e.g., when medicament delivery device 915 a is expected to needreplacement of at least a component thereof). For example, this mayentail one or more of analyte sensor application 425 a, partner deviceapplication 425 b, mobile phone 910 a (or other display device 910,910′), medicament delivery application 625, and medicament deliverydevice 915 a notifying the user of the expected replacement in advance(e.g., replacement is expected in 12 hours).

In the case of medicament delivery device 915 a (or a component thereof)being replaced, the replacement medicament delivery device 915 a canthen essentially mimic the communication of the old medicament deliverydevice 915 a to take the whitelist slot of the old medicament deliverydevice 915 a. This may allow for an overlap in the sensor session withthe medicament delivery session in order to avoid or reduce the effectsof a discontinuity that may arise in connection with the replacement. Byway of example, the old medicament delivery device 915 a may send datato mobile phone 910 a where the data enables analyte sensor system 308to establish communication with the new medicament delivery device moreeasily. This information may be used to bond both the old and newmedicament delivery device to 910 a at the same time. That is, forexample, where analyte sensor system 308 does not have new medicamentdelivery device 915 a's bonding data, mobile phone 910 a can sendbonding data information from old medicament delivery device 915 a tonew medicament delivery device 915 a, such that new medicament deliverydevice 915 a may use the bonding data for facilitating connectionestablishment with analyte sensor system 308. For example, analytesensor system 308 could whitelist advertise to new medicament deliverydevice 915 a, and new medicament delivery device 915 a could thenrespond using bonding information of old medicament delivery device 915a. By way of further illustration, new medicament delivery device 915 amay use the information regarding old medicament delivery device 915 areceived via mobile phone 910 a to replicate the GAPP address,encryption and security keys, other bonding information, and/or timinginformation (e.g., regarding timing of connections, advertisementintervals etc.), as employed by old medicament delivery device 915 a.

In embodiments, for this to occur, the information may need to betransferred from old medicament delivery device 915 a to new medicamentdelivery device 915 a. Other information may be transferred as well,such as for example insulin on board, diagnostics, etc. The transfer maybe facilitated by analyte sensor system 308. For example, DMPI 750 maybe used to access/retrieve the information from old medicament deliverydevice 915 a and share the information with mobile phone 910 a forsubsequent transfer to new medicament delivery device 915 a.

In embodiments, configuration parameters 520 may be used to enableanalyte sensor system 308 to effectively simulate aspects of apreviously implemented analyte sensor system 308. For example,medicament delivery device 315 a may have previously been integratedwith and/or used with a particular analyte sensor system 308 thatemployed a specific algorithm for generating analyte data. In somecases, a clinical trial may have been run using such a particularanalyte sensor system 308, and the clinical trial may have been approvedand/or successful. Configuration parameters 520 used in the particularanalyte sensor system 308 could be stored in medicament delivery device915 a and via DMPI 750 could be used to update configuration parameters520 as stored in analyte sensor system 308. As such, analyte sensorsystem 308 may be configured to in effect simulate the previouslyimplemented analyte sensor system 308.

In embodiments, the simulation of another analyte sensor system 308 maybe accomplished in various ways. For example, accuracy metricsassociated with the simulated analyte sensor system 308, such as MARDand/or other accuracy metrics may be replicated and implemented throughmodifying configuration parameters 520. Sensor algorithms, calibrationsettings, wireless connectivity parameters, and any aspects of otherconfiguration parameters 520 described herein, including connectionmodels and operating modes that were employed previously (for example,in a clinical trial) can also be simulated through the setting and/ormodifying of configuration parameters 520.

In embodiments, a range of values for configuration parameters 520 ofanalyte system sensor system 308 may be defined, for example bymedicament delivery device 915 a, server 920 b, or other remote source,where the range of values represents a set of safe operating parameters.The safe operating parameters can represent or be equivalent toconfiguration parameters previously determined to have satisfied certainrequirements, such as those required by the FDA. Examples of suchconfiguration parameters 520 include additive bias, multiplicative bias,lag, gaps, and sampling rates. Accordingly a set of configurationparameters 520 previously determined to be acceptable may be downloadedto analyte sensor system 308 and implemented with the understanding thatcertain requirements previously tested will be met.

Turning back to FIG. 10A, with respect to system requirements 650 ofpartner device 315, in embodiments, system requirements 650 may largely(but do not necessarily) mirror configuration parameters 520 describedabove. System requirements 650 may include or be associated with one ormore of a battery capacity or power management of partner device 315, anaccuracy requirement of partner device 315, a communication protocol tobe used or supported by partner device 315, a regulatory requirementapplicable to partner device 315, and an expected operational time ofpartner device 315.

With respect to accuracy requirements of partner device 315, certainsystem requirements 650 may relate to calibrations of analyte sensorsystem 308 vis-à-vis the gathering and generation of analyte data. Forexample, system requirements 650 may include a calibration schedule,calibration control, and/or a factory calibration applicable to analytesensor system 308. As discussed elsewhere herein, certain partnerdevices 315 may be capable of tolerating inaccuracies that may begenerated using a factory calibration at analyte sensor system 308(e.g., may be relatively more robust), while other partner devices mayrequire greater accuracy and hence difference calibration settings.Exposing these calibration-related (and other) system requirements 650to analyte sensor system 308 using DMPI 750 can allow configurationparameters 520 of analyte sensor system 308 to be adapted to handle avariety of partner devices 315 with varying degrees of robustness.

In some cases, as will be discussed below with reference to FIGS. 10Aand 10B, the nature and/or extent of system requirements 450 that may bestored on display device 310, and/or whether system requirements 450 arestored on display device 310, may vary depending upon the particulararrangement of analyte sensor system 308, display device 310, and/orpartner device 315. In some cases, system requirements 450 that may bestored on display device 310 may be exposed to or received from ormodified by partner device 315 via DMPI 750 that can allow partnerdevice to set/modify system requirements 450.

With reference to FIG. 10A, in some cases, display device 310 mayinclude system requirements 450, where at least some of systemrequirements 450 may be associated with display device 310 such thatsuch system requirements 450 should be met in order to supportfunctionality according to pre-determined expectations, designconstraints, system specifications, and/or the like as pertaining todisplay device 310. In order to support system requirements 450, displaydevice 310 may use DMPI 750 of analyte sensor system 308 to accessconfiguration parameters 520, in a fashion that may be substantiallysimilar to that described above in connection with partner device 315accessing configuration parameters 520.

In embodiments, system requirements 450 may not pertain to displaydevice 310 (or at least not solely to display device 310), but may (inaddition) pertain to partner device 315. For example, where displaydevice 310 has established a connection with analyte sensor system 308,and it is expected that partner device 315 may be used in the future,display device 310 may obtain and store system requirements 650 ofpartner device 315 as at least part of system requirements 450. Then,display device 310 may, via DMPI 750, set/modify configurationparameters 520 in preparation for partner device 315 establishing aconnection with analyte sensor system 308, such that upon suchconnection being established, operation may go forward according tosystem requirements 650 but without partner device 315 making any (orperhaps minimal) modification to configuration parameters 520. Or, forexample, display device 310 may upload system requirements 450 toanalyte sensor system 308 (e.g., via DMPI 750) with an indication thatsystem requirements 450 pertain to partner device 315, such that a setof configuration parameters 520 may be pre-configured in anticipation ofestablishing connection with partner device 315. Once a connection isestablished between analyte sensor system 308 and partner device 310,the pre-configured set of configuration parameters 520 may beimplemented, and operation may go forward according to systemrequirements 650 but without partner device 315 making any (or perhapsminimal) modification to configuration parameters 520.

FIG. 10A also shows that in embodiments of system 1000, DMPI 750 mayinclude one or more of sub-interfaces or separate interfaces DMPI 750 aand DMPI 750 b, as the case may be. In such embodiments, DMPI 750 a maybe dedicated or allocated to display device 310 for accessing analytesensor system 308, while DMPI 750 b may be dedicated or allocated topartner device 315. Referring to FIG. 9A, in some cases, DMPI 750 a maybe specific to a particular display device 910, 910′ (or group thereof),and/or DMPI 750 b may be specific to a particular partner device 915 (orgroups thereof).

FIG. 10B illustrates example system 1002, in which partner device 315includes system requirements 650 associated therewith. Partner device315 is not connected directly with analyte sensor system 308 in thisexample, but rather is connected therewith through intermediary displaydevice 310. As shown, display device 310 may include DMPI 750′. Partnerdevice 315 may use DMPI 750′ to access, set, and/or modify configurationparameters 420 stored in display device 310. In order to support systemrequirements 650, display device 310 may then access configurationparameters 520 of analyte sensor system 308 using DMPI 750 and may setconfiguration parameters 520 according to the values for configurationparameters 420 set by partner device 315. In this manner, configurationparameters 520 may be adapted in accordance with system requirements 650where partner device 315 is not directly connected to analyte sensorsystem 308.

At this juncture, embodiments of methods and features that may beimplemented in connection with system 900 shown in FIG. 9A will now bedescribed with reference, by way of example to FIGS. 9B through 9F, 9J,and 9K. FIG. 9B is an operational flow diagram illustrating variousoperations that may be implemented, for example, using elements shown inFIG. 9A. FIG. 9B shows operations 932A and 932B of method 930, wheremethod 930 may involve using DMPI 750 (with reference by way of exampleto FIG. 10A) to configure analyte sensor system 308 for wirelesscommunication with partner devices 915. The operations of method 930 maybe used advantageously to implement a flexible and adaptable systemwherein different partner devices from different manufacturers may beaccommodated through the use of a configurable diabetes managementpartner interface.

At operation 932A, method 930 includes analyte sensor system 308receiving authorization to provide one of partner devices 915 (forexample, medicament delivery device 915 a) with access to configurationparameters 520 (referencing FIG. 5B by way of example) stored in storage515 (referencing FIG. 3C for example) of analyte sensor system 308. Theauthorization may be received from, for example, a user who may providethe authorization via mobile phone 910 a or other display device 910,910′ using caps PAN 902 and/or caps WAN 904. The access to configurationparameters 520 may be provided via DMPI 750. At operation 932B, method930 involves analyte sensor system 308 setting or causing a modificationto configuration parameters 520, whereas described above themodification may be made according to system requirements 650 of the onepartner device 915. Operation 932B occurs responsive to input received,for example over a link in PAN 902 (e.g., link 906 d, 906 h, 906 i, 906j) from the one partner device via DMPI 750. In embodiments, the onepartner device 915 may be implemented as an automatic insulin deliverydevice (for example, an insulin pump) or a manual insulin deliverydevice (for example, an insulin pen).

As described above, in embodiments, configuration parameters 520 mayinclude one or more of a set of wireless connectivity parameters (forexample, relating to a white list maintained for analyte sensor system308, advertisement messaging, connection models, operating modes, etc.),a set of access control parameters (for example, relating to what typesof devices can connect to analyte sensor system 308 while medicamentdelivery device 915 a is connected to analyte sensor system 308, and/orwhat type of signaling such devices may exchange with analyte sensorsystem 308), a set of analyte data parameters (for example, relating toaccuracy, security, and/or calibration etc.), a set of power controlparameters, or any other parameters that may be used in system 900. Asalso described herein, and embodiments, system requirements 650 mayinclude or be associated with one or more of a battery capacity of theone partner device 915, and accuracy requirement of the one partnerdevice 915, a communication protocol to be used or supported by the onepartner device 915, a regulatory or other safety requirement applicableto the one partner device 915, and an expected operational time of theone partner device 915.

In embodiments, the set of wireless connectivity parameters withinconfiguration parameters 520 includes a condition under which the onepartner device 915 is to be removed from a white list maintained foranalyte sensor system 308. In embodiments, operation 932B optionallyincludes additional operations as illustrated by way of example in FIG.9C. For example, FIG. 9C shows that at operation 934A, operation 932B(analyte sensor system 308 setting or causing the modification toconfiguration parameters 520 according to system requirement 650 of theone partner device 915) may include analyte sensor system 308 settingthe condition such that the one partner device 915 is to be removed fromthe whitelist when a battery level of the one partner device 915 meetsthe threshold.

In embodiments, the set of access control parameters withinconfiguration parameters 520 includes an advertisement structure oraspects thereof (for example, advertisement structure 622, referencingFIG. 6 and elements thereof). In embodiments, operation 932B optionallyincludes at operation 934A analyte sensor system 308 using DMPI 752 setor modify by the advertisement structure or aspects thereof, for exampleto effect a trade-off between connection reliability and powerconsumption.

In embodiments, the set of analyte data parameters within configurationparameters 520 includes a calibration period for analyte sensor system308. In such embodiments, operation 932B optionally includes atoperation 934C analyte sensor system 308 using DMPI 750 to set or modifythe calibration period. In some cases, the calibration period may be setto zero or none. For example, the calibration period may be set inaccordance with system requirements 650 related to accuracy required bythe one partner device 915 in connection with the delivery ofmedicaments. In embodiments, the set of analyte data parameters includesa factory calibration code for analyte sensor system 308. Operation 932Bmay include at operation 934D analyte sensor system 308 using DMPI 7502receive from the one partner device 915 an indication to use the factorycalibration code, according to system requirements 650 of the onepartner device 915.

With further reference to FIG. 9C, in embodiments, the set of wirelessconnectivity parameters within configuration parameters 520 includessettings stored in server 920 b (or for example server system 334 aand/or 334 b, with reference to FIG. 8). In such embodiments, operation932B may include at operation 934E analyte sensor system 308 using DMPI750 to configure analyte sensor system 308 to use services provided viaserver 920 b (or server system 334 a and/or 334 b). To illustrate,configuration parameters 520 may be set/modified in order to enableanalyte sensor system 308 to support the services. For example, whereanalyte sensor system 308 may not have a direct connection to WAN 904,such services may be provided using an intermediate device connected toWAN 904, such as for example mobile phone 910 a.

Operation 932B optionally includes at operation 934F analyte sensorsystem 308 using DMPI 752 configure analyte sensor system 308 totransmit diabetes management feedback to one or more display devices910, 910′ connected to or in range of analyte sensor system 308.Operation 934F is executed in response to the services provided viaserver 920 b, in certain embodiments. Diabetes management feedback mayinclude, by way of example, direction or instruction relating to auser's health or actions that may affect analyte levels (for exampleinsulin levels) within the user. Such direction or instruction may beprovided by the user's health cover provider, friend, or family member,etc., connected, at least indirectly, to analyte sensor system 308 viaat least WAN 904. At operation 934G, if the services provided via remoteserver 920 b become unavailable, analyte sensor system 308 may use DMPI752 configure analyte sensor system 308 to disable the use of theservices and send a related notification to relevant display devices910, 910′ connected to or in range of analyte sensor system 308. In thismanner individuals or entities monitoring the user via server 920 b canbe made aware if a disconnection occurs and take action accordingly.

FIG. 9D is an operational flow diagram illustrating various operationsthat may be implemented, for example, using elements shown in FIG. 9A.FIG. 9D shows operations 938A and 938B of method 936, where method 936may involve using DMPI 750 (with reference by way of example to FIG.10A) to configure wireless communications among analyte sensor system308 and one or more of display devices 910, 910′ and/or partner devices915. The operations of method 936 may be used advantageously toimplement a flexible and adaptable system wherein different partnerdevices from different manufacturers may be accommodated through the useof a configurable diabetes management partner interface.

As shown in FIG. 9D, method 936 includes at operation 938A analytesensor system 308 enabling a first wireless signal communication path.The first wireless communication signal path is between analyte sensorsystem 308 and one of display devices 910, 910′, where here forillustration purposes mobile phone 910 a (and, for example link 906 g)will be discussed. Nevertheless, it should be appreciated that method936 may include enabling the first wireless signal communication pathbetween analyte sensor system 308 and any of display devices 910, 910′.As further illustrated at operation 938A also, for the first wirelesscommunication path, analyte sensor system 308 provides mobile phone 910a with a first degree of access or control over analyte sensor system308. For example, in some cases the first degree of access or controlcan allow mobile phone 910 a to send command control signaling toanalyte sensor system 308. In other cases, for example depending on theoperation mode that is implemented, the first degree access or controlmay not allow mobile phone to send command control signaling.

Method 936 also includes, at operation 938B, analyte sensor system 308enabling a second wireless communication path. The second wirelesscommunication path is between analyte sensor system 308 and one ofpartner devices 915. Analyte sensor system 308 enabling the secondwireless communication path per operation 938B also includes causing amodification to the first degree of access or control in order toimplement a second degree of access or control according to systemrequirements 650 of the one partner device 915. The modification iscaused in response to input received from the one partner device 915 viaDMPI 750. My way of example analyte sensor system 308 may receive theinput from the one partner device 915, and in response thereto use DMPI752 modify configuration parameters 520 and thereby modify the firstdegree of access or control.

In embodiments, operation 938B optionally includes additional operationsas illustrated by way of example in FIG. 9E. For example, as shown inFIG. 9E, operation 938B may include operation 942A. According tooperation 942A, causing the modification to the first degree of accessor control, in connection with operation 938B, may include using DMPI750 to set or change configuration parameters 520 implemented by analytesensor system 308, in accordance with system requirements 650 of the onepartner device 915. In embodiments configuration parameters 520 includeone or more of access control parameters for display devices 910, 910′(e.g., mobile phone 910 a) and/or partner devices 915 (e.g., medicamentdelivery device 915 a), accuracy or calibration parameters for analytesensor system 308, and wireless communication parameters forcommunications to be exchanged between/among analyte sensor system 308and one or more display devices 910, 910′ and partner devices 915.

FIG. 9F shows that operation 942A may, in example implementations,include operations 946A to 946C. Accordingly, in embodiments of method936, operation 942A (using DMPI 750 to set or change configurationparameters 520) optionally includes granting to the one partner device915 permission to configure the accuracy or calibration parameters foranalyte sensor system 308, mentioned above, in accordance with systemrequirements 650. Additionally operation 942A may include at operation946B revoking from, for example, mobile phone 910 a permission toconfigure the accuracy or calibration parameters for analyte sensor 308.For example such permission may be revoked in accordance with certainoperating modes described herein.

In embodiments, the access control parameters include a whitelist fordevices connectable to analyte sensor system 308, for example partnerdevices 915 and/or display devices 910, 910′. In some such embodimentsat operation 946C using DMPI 750 to set or change configurationparameters 520, per operation 942A of method 936, includes setting ormodifying an amount of time the one partner device 915 is to remain onthe whitelist before being removed from the whitelist.

FIG. 9J is an operational flow diagram illustrating various operationsthat may be implemented, for example, using elements shown in FIG. 9A.FIG. 9J shows operations 986A through 986M that may be included inembodiments of method 984, where method 984 may involve using DMPI 750(with reference by way of example to FIG. 10A) to facilitate theexchange of wireless communications with analyte sensor system 308. Theoperations of method 984 may be used advantageously to implement aflexible and adaptable system wherein different partner devices fromdifferent manufacturers may be accommodated through the use of aconfigurable diabetes management partner interface.

As shown in FIG. 9J, method 984 includes at operation 986A using DMPI752 establish a first connection between analyte sensor system 308 and afirst partner device (for example purposes only, medicament deliverydevice 915 a will be referred to in connection with the first partnerdevice). At operation 986B, method 984 includes analyte sensor system308 providing medicament delivery device 915 a with access toconfiguration parameters 520 (referencing FIG. 3C, by way of example)via DMPI 750. At operation 986C, method 984 includes setting or causinga first modification to configuration parameters 520 in response toinput received from medicament delivery device 915 a via DMPI 750. Byway of example, medicament delivery device 915 a may send the signalreceived as input at analyte sensor system 308 using link 906 d(referencing FIG. 9A for example). Setting or causing the firstmodification is done according to system requirements 650 of medicamentdevice 915 a. At operation 986D, method 984 includes using DMPI 750 toestablish a second connection between analyte sensor system 308 and asecond partner device (for example purposes only, insulin pen 915 d willbe referred to in connection with second partner device). Inembodiments, using DMPI 750 to establish the second connection occursafter the first connection has been terminated. At operation 986E,method 984 includes analyte sensor system 308 providing insulin pen 915d with access to configuration parameters 520 via DMPI 750. At operation986F, method 948 additionally includes causing a second modification toconfiguration parameters 520 in response to input received from insulinpen 915 d via DMPI 750. By way of example insulin pen 915 d may send thesignal received as input at analyte sensor system 308 using link 906 j.Causing the second modification is done according to system requirements650 of insulin pen 915 d.

In embodiments, method 984 may further include at operation 986G,responsive to analyte sensor system 308 receiving identificationinformation for a third partner device (for example purposes only, firstinsulin pump 915 b will be referred to in connection with the thirdpartner device), using DMPI 750 to attempt to establish a thirdconnection between analyte sensor system 308 and first insulin pump 915b. In some cases, the identification information for first insulin pump915 b is stored in server 920 b (or, for example, server system 334 aand/or 334 b, with reference to FIG. 8). The identification informationmay indicate whether first insulin pump 915 b is authorized tocommunicate with analyte sensor system 308. In embodiments, as shown byway of example in FIG. 9K, analyte sensor system 308 receiving theidentification information for first insulin pump 915 b in connectionwith operation 986G includes at operation 990 in on it sensor system 308receiving the identification information from one of display devices 910(for example, mobile phone 910 a) that received the identificationinformation from server 920 b (or, for example, server system 334 aand/or 334 b, with reference to FIG. 8).

Referring back to FIG. 9J, embodiments of method 984 may additionallyinclude at operation 986H, responsive to analyte sensor system 308receiving the identification information for first insulin pump 915 b,using the identification information to determine whether first insulinpump 915 b is authorized to communicate with analyte sensor system. Atoperation 986J, method 984 may include, responsive to determining thatfirst insulin pump 915 b is not authorized to communicate with analytesensor system 308, denying the attempt to establish the third connectionbetween analyte sensor system 308 and first insulin pump 915 b. Atoperation 986K, method 984 may include, responsive to determining thatfirst insulin pump 915 b is authorized to communicate with analytesensor system 308, using DMPI 750 to establish the third connectionbetween analyte sensor system 308 and first insulin pump 915 b.

In example implementations, determining that first insulin pump 915 b isnot authorized to communicate with analyte sensor system 308 (e.g., inconnection with operation 986J) occurs at a first time, determining thatfirst insulin pump 915 b is authorized to communicate with analytesensor system 308 (e.g., in connection with operation 986K) occurs at asecond time, and the identification information for first insulin pump915 b is updated at server 920 b between the first time in the secondtime. That is, for example, between the first and second time firstinsulin pump 915 b may have been authorized to communicate with analytesensor system 308 through updated identification information received atthe cloud. One of skill in the art upon studying the present disclosurewill appreciate that identification information may be stored in any ofthe elements shown in system 900 and updated, such that authorizationfor partner devices 915 and/or display devices 910, 910′ may be providedand/or controlled via PAN 902 and/or WAN 904 and elements interconnectedtherein as shown in FIG. 9A.

In embodiments, method 984 further includes at operation 986L,responsive to establishing the third connection between analyte centersystem 308 and first insulin pump 915 b, causing a third modification toconfiguration parameters 520 in response to input received from firstinsulin pump 915 b via DMPI 750. By way of example first insulin pump915 b may send the signal received as input at analyte sensor system 308using link 906 h. Causing the third modification is done according tosystem requirements 650 of first insulin pump 915 b. In some cases,system requirements 650 of first insulin pump 915 b are stored in server920 b (or, for example, server system 334 a and/or 334 b, with referenceto FIG. 8). In some such cases, method 984 may further include atoperation 986M causing a fourth modification to configuration parameters520 in response to input received via DMPI 750 where the fourthmodification is done according to an updated version of systemrequirements 650 of first insulin pump 915 b stored at server 920 b.That is, for example according to embodiments of the present disclosure,system requirements 650 for partner devices 915 may be updateddynamically via cloud connected mechanisms, and/or using any of theother elements interconnected in system 900 via PAN 902 and/or WAN 904or the like.

Certain aspects that may be involved with interfacing analyte sensorsystem 308 with additional partner devices 915 using DMPI 750 will nowbe described. As described above, partner devices 915 may includeinsulin pen 915 d. Unlike automated medicament delivery devices, such asfirst and second insulin pumps 915 b and 915 c, insulin pen 915 dtypically uses manual intervention in order to deliver insulin. As aresult, in embodiments, some of the concerns expressed herein regardingthe automatic delivery of medicaments, including below in connectionwith operating modes, may not apply. Such concerns may, for example,relate to the effect of interference on the accuracy/precision ofmedicaments that are delivered.

In embodiments, as discussed above, insulin pen 915 d can determinebolus values the user has calculated and/or how much insulin wasdelivered. For example, a bolus calculator can be used in conjunctionwith insulin pen 915 d. Such a bolus calculator could be implemented onmobile phone 910 a and use analyte data received from analyte sensorsystem 308 and manual entry from a carbohydrate counter. Using thisinformation, the bolus calculator may provide a suggestion of how muchinsulin to dose. This information could be displayed on mobile phone 910a, or the information could be transmitted to insulin pen 915 d. Whereinsulin pen 915 d includes a display, the transmitted information can bedisplayed to the user using the display of insulin pen 915 d. The usermay then approve the dosage suggestion or may adjust the calculateddosage. Once the user administers a dose of insulin using insulin pen915 d, dosage related information may be sent back to analyte sensorsystem 308 and/or mobile phone 910 a, such that insulin on board may betracked. Additionally or alternatively, the user may manually enterdosage information into analyte sensor system 308 and/or mobile phone910 a, such that insulin on board may be tracked.

Where insulin pen 915 d includes a display and/or other input/outputfunctions/mechanisms, insulin pen 915 d may be more amenable to directcommunication with analyte sensor system 308. By way of example, analytesensor system 308 may or may not add insulin pen 915 d to a white list,may set or modify configuration parameters 520 responsive to systemrequirements 650 of insulin pen 915 d, etc. Moreover, analyte data, EGV,and/or insulin related data may be displayed on insulin pen 915 d.Further, calibrations could be entered directly into insulin pen 915 d.In terms of the bolus calculator, where insulin pen 915 d includes adisplay, the bolus calculator may more effectively be implemented oninsulin pen 915 d, and likewise a decision supporting module for thebolus calculator may be implemented on insulin pen 915 d more easily. Inembodiments, the piconet arrangement of system 900 may be adaptive insuch a way that direct communication between analyte sensor system 308and insulin pen 915 d is based on the presence of mobile phone 910 a,for example in PAN 902. For example, in some cases, mobile phone 910 amay not be needed if insulin pen 915 d includes a display and isconnectable within PAN 902. As another feature of insulin pen 915 d carbcounting and/or meal calculation could be integrated.

Referring again to FIG. 9A, additional embodiments of system 900 mayleverage the increasing number of every day devices and objects that arebeing connected through wireless technology. By way of example, partnerdevices 915 may include a smart refrigerator that detects which and howmany of certain food objects and/or drinks are consumed by a given userand relays this information to mobile phone 910 a where the informationmay be integrated with analyte data and/or medicament delivery data. Theintegration of such information may enable useful characterizations ofhow the user's health, including for example insulin and blood glucoselevels and the like, vary as a result of the food/drink the userconsumes, including characterizing such variations as a function oftime. Other connected devices that may provide useful information,including for example analyte data, include gym equipment, scubaequipment, and airplanes, trains, cars, boats, or other recreationalvehicles. Such devices can provide for analyte data collection underspecial circumstances and in an ongoing fashion that is reasonablyconvenient for users.

In another example, special medical circumstances or other situationsinvolving urgency may create the need for additional features. Forexample where user is relying on mobile phone 910 a to track analytedata and provide a CGM history/profile, the user's mobile phone 910 amay be locked. It may thus be difficult for first responders to usemobile phone 910 a to get insight into the user's analyte-relatedinformation. Embodiments of the present disclosure include providing aninterface that enables access to certain information in specialcircumstances without unlocking mobile phone 910 a. For example, DMPI750 may be configured to receive a special key or override signalreserved for first responders such as police, medical professionals,caregivers etc. In some cases, an override mode may be enabled based ongeographical location, such that for example, when a user enters ahospital the user's analyte data may be accessed without unlockingmobile phone 910 a. It should be appreciated that these features may beapplied to other display devices 910, 910′ and/or partner devices 915.

In some cases, sensor 10 may be adapted to gather information onanalytes related to muscle fatigue. Analyte data may then be provided tothe user to help the user avoid becoming overly fatigued. This may beuseful to, for example, athletes, military personnel, etc. In somecases, sensor 10 may be adapted to gather information on analytesrelated to alcohol consumption. The analyte data may then be used toprevent drunk driving. For example, analyte sensor system 308 may signalthe user's vehicle to enforce security measures that prevent the userfrom operating the vehicle and/or to simply warn the user or otheroccupants of the vehicle that the users blood alcohol concentrationexceeds predetermined levels.

J. Integration/Coordination of Alerts

In some embodiments, the alerts and alarms and/or notification that aregenerated in various devices in system 900, for example, may becoordinated to notify users more efficiently. Here, the coordination andintegration of alerts and alarms is discussed more particularlyreferencing FIG. 9A and the example context of system 900. In thecontext of system 900, a problem or issue may occur where any number ofdisplay devices 910, 910′, partner devices 915, and so forth areconnectable to analyte sensor system 308 and/or medicament deliverydevice 915 a. More specifically, in the context of system 900 there maybe situations in which, due to the number of devices being used, theremay be many potential combinations of alarms that may be triggered(e.g., related to analyte data, medicament data, battery levels,diagnostics, device status, etc.), some of which may be redundant and/orannoying and/or unnecessary. As such, when display devices 910, 910′and/or partner devices 915 are connected in system 900, in some cases,users may not want to receive multiple alarms on each of the devicestriggered by the same event (e.g., Hypoglycemia). By way of example,analyte sensor application 425 a that may run in mobile phone 910 a maytrigger an alarm when a user's glucose level is low. Additionally, uponreceiving analyte data, medicament delivery device 915 a and/orapplication 625 running thereon may trigger an alarm based on the usersglucose level. In certain situations the triggering of both alarms isunnecessary and potentially inefficient, redundant, or undesirable.Here, it should be noted that where medicament delivery device 915 adelivers medicaments automatically, no analyte related alerts should benecessary. Thus, to a certain extent the alert describes here may bemore useful when the delivery of medicaments is not automatic.

Accordingly, embodiments of the present disclosure, including forexample with respect to system 900, involve the intelligent coordinationof alerts. With respect to system 900, the alerts may be coordinatedacross and based on the configuration of capital PAN 902 and WAN 904. Ata high level, the coordination of alerts may be facilitated based onuser input, based on system requirements 650 of partner devices 915,etc. In terms or alert coordination based on user input, the user mayalso configure all alerts for display devices 910, 910′ and/or partnerdevices 915 etc., for example, through user interface 435, analytesensor application 425 a, and/or partner device application 425 b(referencing FIG. 4). The user can use user interface 435 of mobilephone 910 a, for example, to configure how alerts are set and providedon different display devices 910, 910′ and/or partner devices 915. Anydevice shown in FIG. 9A may be used for coordinating alerts based onuser input.

For example, assuming alerts are enabled at both mobile phone 910 a andmedicament delivery device 915 a, and further assuming that additionaldisplay devices 910, 910′ are in use or may be in use, the user mayfirst navigate, e.g., sensor application 425 a to select a certaindisplay device 910, 910′ for primary user interaction. This could alsoinclude, in some cases specifying a hierarchy of user preferences fordisplay devices 910, 910′. By way of example, if sensor application 425a running on mobile phone 910 a is selected as the primary interactionmeans, all alerts related to analytes, and most if not all alertsrelated to medicament delivery device 915 a may issue via application425 a, at least as a first line of defense. Of course, the user'sselection can be modified if, for example, the primary user interactiondevice becomes inoperable. For example a selected secondary device maybe shifted to become the primary interaction means and/or a secondarydevice may be chosen automatically from in-range devices. Additionally,a fallback hierarchy may be established based on user input, apredetermined scheme, etc.

In embodiments, if the user does desire to employ multiple devices foralerts the user can select a sequence of alerts in terms of whichdevices the alert should be triggered on in which order, as well as whattype of alert may be used for particular device and system 900. Alertscan also be configured as a function of time or as a function of events,such that for example at night, during a movie, during a moot meeting,alerts may be haptic. Or a heavy sleeper may want to configure alerts tobe increased in volume during nighttime.

In some cases, to provide alerts more efficiently, escalating alerts maybe implemented. For example, an alert may be provided as a first measureat mobile phone 910 a and/or wearable device 910 c. Then, if the alertis not acknowledged, the alert may be provided at medicament deliverydevice 915 a. Additionally, alerts may change in type and/or intensityduring the escalation process. If not acknowledged by a certain point,the alert may be propagated to entities or individuals monitoring theuser (e.g., via server 920 b) and/or emergency services providers.

Embodiments, partner devices 915 may govern the coordination of alerts.In some example situations, alerts may be controlled via configurationparameters 520. For example if certain alert characteristics are definedin system requirements 650 of medicament delivery device 915 a, suchalert characteristics may be implemented in system 900 by medicamentdelivery device 915 a using DMPI 752 sat configuration parameters 520accordingly.

In embodiments involving the implementation of medicament deliverydevice 915 a as a pump (e.g., an insulin pump), special considerationsmay be made with respect to alerts. For example, certain pump-specificfaults (e.g., undetected cannula problems) may result in medicaments notbeing delivered as expected. Hence, a user may experience, for example,hypoglycemia or may even develop ketones. Additional pump-specificfaults may involve battery failure, drainage, or other mechanicalfailures.

Accordingly, embodiments of the present disclosure involve theconfiguration of alerts triggered by pump-specific faults. By way ofexample, where the user is relying on a certain remote device (e.g.,display device 910, 910′ etc.) connected to medicament delivery device915 a under the intermittent connection model, four pump specificfaults, it may be desirable to notify the user of the alert withoutwaiting for the next transmission opportunity. Thus, medicament deliverydevice 915 a may temporarily override the setting of the remote devicehas the sole or even primary device for providing alerts in order toprovide the alert to the user more quickly. Alternatively, connecting tothe medicament delivery device 915 a using the continuous connectionmodel may be a way to avoid this issue.

In addition, for any fault or error related issues with medicamentdelivery device 915 a, diagnostic information may be provided to analytesensor system 308. In embodiments, such diagnostic information can beshared with analyte sensor system 308 using DMPI 750. For example,configuration parameters 520 may include a diagnostics field or arraythat may be populated with such information. The diagnostic informationcould then be propagated to other devices in system 900, includingmobile phone 910 a, mirror 910 d, etc. For example, such information maybe propagated via mesh networking, a series of network of connecteddevices, including common-place devices, and/or machine-to-machinetransactions, and the like.

In certain embodiments, pump-specific faults may be difficult to detect.As an example, if there is only a partial cannula occlusion, and alarmmay not be triggered at medicament delivery device 915 a (e.g., noproblem may detected due to the partial nature of the occlusion). Suchproblems may arise, because, for example, each time an infusion set ischanged, there is a risk that the infusion site or cannula does not havea proper insulin absorption or is completely or partially occluded.Occlusions, particularly partial occlusions, for example involving akink in cannula, may be difficult to detect. This is problematic becauseundetected cannula problems may lead to hypoglycemia and evenketoacidosis, which can be life-threatening. As such, standards of carecan be implemented to monitor for such difficult to detect problems,including monitoring insulin delivery mechanisms. But periodicmonitoring may be burdensome and/or expensive. Additional issues mayarise where a partial occlusion may cause the user's blood glucose levelto rise, but due to other factors the user may not be able to detect thereason behind the blood glucose level change (for example, the user maysuspect that the book level change has resulted from the user's foodconsumption).

Accordingly, embodiments of the present disclosure involve medicamentdelivery device 915 a providing information related to the functionalityof medicament delivery device 915 a via analyte sensor application 425a, analyte sensor system 308, and/or other means in system 900. Suchinformation may include, by way of example, reservoir changeinformation, e.g., pump rewind time, pump prime time, cannula fill timeand/or amount. Such information may include, for example fluid pressuremetrics or other measures that are used to generate occlusion alerts,e.g., a combination of cannula fills, reservoir changes, and pumpprimes, which may be used to determine when part of an infusion set mayhave been changed. Additionally, fluid pressure may be used to furtherdevelop an individualized characterization for the user that can dictatewhen alarms may be appropriate vis-à-vis infusion set issues.

In embodiments the above information may be combined with analyte datain order to assist in distinguishing between blood glucose level changesthat result from infusion set issues and such changes that may resultfrom the user's consumption of sugar, for example. By way ofillustration, the analyte data may indicate that the change in bloodglucose level is related to the user's consumption of sugar whereas theinfusion set information can be used to identify the partial occlusionissue.

K. Operating Modes

With further reference to FIG. 9A, embodiments of the present disclosurerelated to various operating modes that may be implemented in connectionwith system 900 will now be described. At a high level, it should beappreciated that different operating modes may be implemented dependingupon, for example, whether any partner devices 915 are connecting toanalyte sensor system 308 and whether such partner devices are adaptedto deliver medicaments to a user are available for connection withanalyte sensor system 308, and/or in some cases depending further uponsystem requirements 650 of partner devices 915. In example deployments,a medicament delivery operating mode may be specific to a configurationof system 900 that utilizes at least one partner device 915 adapted todeliver medicaments to a user (e.g., medicament delivery device 915 a)and does not utilize any display devices 910, 910′. As another example,a display operating mode may be specific to a configuration of system900 that does not utilize at least one partner device 915 adapted todeliver medicaments to a user. A hybrid operating mode may be specificto a configuration of system 900 that utilizes at least one partnerdevice 915 adapted to deliver medicaments to a user and that utilizes atleast one display device 910, 910′. Features for each of these operatingmodes will now be discussed.

In embodiments, the medicament delivery operating mode may be employedin order to accommodate system requirements 650 of medicament deliverydevice 915 a that is adapted to delivery medicaments to a user (e.g., aninsulin pump or other automatic medicament delivery device), wheresystem requirements 650 are such that medicament delivery device 915 ashould have a dedicated connection with analyte sensor system 908. Forexample, such system requirements 650 may indicate that medicamentdelivery device 915 a is not relatively robust. In the medicamentdelivery operating mode, remote devices other than medicament deliverydevice 915 a (e.g., display devices 910, 910′) may be blacklisted fromconnecting to analyte sensor system 908.

By way of example, medicament delivery device 915 a may implement themedicament delivery operating mode by using DMPI 750 to access andset/modify configuration parameters 520, and in some cases specificallywireless connectivity parameters of configuration parameters 520, toremove all remote devices (e.g., display devices 910, 910′ and otherpartner devices 915) from the whitelist. Additionally or alternatively,medicament delivery device 915 a may use DMPI 750 to set access controlparameters of configuration parameters 520 such that analyte sensorsystem 908 accepts connection requests from medicament delivery device915 a only. For example, medicament delivery device 915 a may include aflag or other information in a packet sent with a connection requestsent to analyte sensor system 308, where the flag or other informationindicates the connection request originated from medicament deliverydevice 915 a or a class of devices that includes medicament deliverydevice 915 a.

The medicament delivery operating mode may be entered automatically insome cases. For example, a connection may be established betweenmedicament delivery device 915 a and analyte sensor system 308,following which medicament delivery device 915 a may be registered withanalyte sensor system 308 and whitelisted. Thereupon, analyte sensorsystem may enter into and operate in the medicament delivery operatingmode. This operating mode may be changed subsequently, for example ifsystem requirements 650 of medicament delivery device 915 a can supportthe hybrid operating mode, or for example if medicament delivery devices915 a is removed from the whitelist.

According to embodiments, entering the medicament delivery operatingmode may require authentication of medicament delivery device 915 a. Forexample, in some cases, the medicament delivery operating mode may beenabled using analyte sensor application 425 b, referencing FIG. 4. Auser wishing to use medicament delivery device 915 a may download and/orinstall analyte sensor application 425 a and/or partner deviceapplication 425 b. Then partner device application 425 b mayauthenticate itself and/or medicament delivery device 915 a forcommunication with analyte sensor application 425 a. This authenticationmay be by exchange hash values or other means. Following authentication,analyte sensor system 308 may enter the medicament delivery operatingmode medicament. In some cases, user input (including, e.g., password,fingerprint, or facial recognition input) may be solicited to authorizeentering the medicament delivery operating mode.

In embodiments, when operating in the medicament delivery operatingmode, analyte sensor system 308 may include in advertisement messages amode indicator that indicates to remote devices receiving theadvertisement messages that analyte sensor system 308 is operating inthe medicament delivery mode. The mode indicator may be encrypted. Insome cases, upon receiving such advertisement messages, the remotedevices other than medicament delivery device 915 a may be adapted todetect from the mode indicator that analyte sensor system 908 isoperating in medicament delivery mode and therefore such remote devicesmay ignore the advertisement messages. In some cases, upon receivingsuch advertisement messages, the remote devices other than medicamentdelivery device 915 a may respond with a connection request, but analytesensor system 308 may be adapted to ignore the connection request upondetecting that the connection request did not originate from medicamentdelivery device 915 a (or a class of devices that includes medicamentdelivery device 915 a).

Additional techniques may be employed for preventing remote devicesother than medicament delivery device 915 a from communicating withanalyte sensor system 308. For example, medicament delivery device 915 amay use DMPI 750 to set configuration parameters 520 of analyte sensorsystem 308, and by way of specific example may set wireless connectivityparameters thereof, such that medicament delivery device 915 a mayoccupy all the available advertisement slots. In some cases, this mayinvolve medicament delivery device 915 a using DMPI 750 to modifyconfiguration parameters 520 such that there is only one advertisementslot and that slot is allocated to medicament delivery device 915 a. Orone slot may be occupied by medicament delivery device 915 a while theother slot may be occupied by controller 645. As such, it may be thecase that no other remote device will be able to connect with analytesensor system 308.

More generally, in connection with operating in the medicament deliveryoperating mode (and/or the hybrid mode), analyte sensor system 308 maygive medicament delivery device 915 a permission to configure thewhitelist maintained by analyte sensor system 308, including age off(e.g., time out) rules for other devices (e.g., display devices 910,910′) or classes of devices.

In embodiments, the display operating mode can be used when no partnerdevices 915 adapted to deliver medicaments to a user (e.g., insulinpumps 915 b, 915 c or other automatic medicament delivery device,insulin pen 915 d, or more generally medicament delivery device 915 a)are utilized within system 900. Typically, the display operating modemay be less restrictive than the medicament delivery operating mode,because in the display operating mode, system requirements 650 ofmedicament delivery device 915 a are not imposed upon the operation ofanalyte sensor system 308. Thus, in example implementations of thedisplay operating mode, various display devices 910, 910′ may establishconnections and receive/send communications related to analyte data,control, etc.

In embodiments, where system 900 has been operating in medicamentdelivery mode, but medicament delivery device 915 a stops communicatingwith analyte sensor system 308 (e.g., because the user powered down ordetached medicament delivery device 915 a, or the device otherwisestopped functioning), analyte sensor system 308 may remove medicamentdelivery device 915 a from the whitelist and fall back to displayoperating mode (assuming no other medicament delivery device 915 a isbeing utilized). This fall back may involve restoring configurationparameters 520 to a state that existed prior to configuration parameters520 being set/modified by medicament delivery device 915 a using DMPI750.

In embodiments, the hybrid operating mode may be used, for example insystem 900, where it is feasible to accommodate system requirements 650of medicament delivery device 915 a that is adapted to delivermedicaments to a user (e.g., an insulin pump or other automaticmedicament delivery device), while at the same time providing otherremote devices (e.g., display devices 910, 910′) with at least theopportunity to receive analyte data from analyte sensor system 308 (inaddition to medicament delivery device 915 a receiving the analytedata). For example, where medicament delivery device 915 a may besufficiently robust to allow remote devices other than medicamentdelivery device 915 a to receive analyte data in a display only state,however, medicament delivery device 915 a may not be robust enough todeal with such remote devices additionally sending command/controlsignaling to analyte sensor system 308.

Thus, in this example of the hybrid operating mode, while displaydevices 910, 910′ may be able to receive analyte data (e.g., usingcommunication session 720, 740, or 760, with reference to FIGS. 7A-7C),such display devices 910, 910′ may not send calibration commands toanalyte sensor system 308. In this manner, system 900 may operate inaccordance with system requirements 650 of medicament delivery device915 a, while at the same time allowing display devices 910, 910′ toprovide, for example, a trend graph to the user and/or allowing analytedata to be provided to be monitored using a remote devices connected viaWAN 904 (e.g., by a medical professional or friend or family member ofthe user). Displayable analyte data may be encrypted for communicationto various devices via PAN 902 and/or WAN 904. In embodiments, alertsmay be controlled and/or somewhat limited vis-à-vis display devices 910,910′. For example, alerts may be channeled through medicament deliverydevice 915 a instead of being provided from all devices receivinganalyte data from analyte sensor system 308.

In embodiments of the hybrid operating mode, system requirements 650 mayreflect that medicament delivery device 915 a is relatively more robust,and thus remote devices other than medicament delivery device 915 a maybe allowed to communicate with and send command/control messages toanalyte sensor system 308, and/or may be able to access accuracy orcalibration parameters, start/stop events, etc. relative to analytesensor system 308. For example, system requirements 650 may indicatethat medicament delivery device 915 a is sufficiently robust to allowremote devices other than medicament delivery device 915 a to not onlyreceive analyte data but also to send command/control signaling toanalyte sensor system 308 without disturbing the operation of medicamentdelivery device 915 a. Thus, in this example of the hybrid operatingmode, display devices 910, 910′ may be able to send calibration commandsto analyte sensor system 308, and system 900 may nevertheless operate inaccordance with system requirements 650 of medicament delivery device915 a.

The hybrid operating mode may be implemented using DMPI 750 to setconfiguration parameters 520 of analyte sensor system 308, for example,to allow remote devices other than medicament delivery device 915 a toconnect to analyte sensor system 308 and/or receive analyte datatherefrom (e.g., in a display only state for such remote devices), andin some cases may allow such remote devices to send command/controlsignaling to analyte sensor system 308. For example, this may beaccomplished through medicament delivery device 915 a using DMPI 750 toset the access and control parameters described above. Additionally,DMPI 750 may be used to set the wireless connectivity parametersdescribed above in order to, for example, send analyte data to theremote devices where the analyte data can be included in advertisementmessages transmitted (e.g., broadcasted) by analyte display device 308(for example per communication session 760 with reference to FIG. 7C).The hybrid mode, in embodiments, may require authentication (e.g., asdescribed above for the medicament delivery mode) before being employed.

In some instances, the user may control which version of the hybridoperating mode is employed—e.g., whether devices other than medicamentdelivery device 915 a may send control/command signaling relating toanalyte data. For example, user interface 435 of mobile phone 910 a mayprovide a GUI that allows the user to select between versions of thehybrid operating mode. In some cases, the GUI may additionally providethe user with warnings, recommendations, and/or system performanceimplications associated with choosing one version of the hybridoperating mode versus another version. It is also contemplated thatother operating modes (e.g., the medicament delivery mode, display onlymode) as described above, may also be user-selectable, for example, viauser interface 435.

As alluded to above, embodiments of the present disclosure includechanging between the above-described operating modes. For example, ifthe user decides to stop using medicament delivery device 915 a, or ifmedicament delivery device 915 a experiences battery failure or someother malfunction, then system 900 may transition from employing themedicament delivery operating mode or the hybrid operating mode to thedisplay operating mode. Or, for example, the transition among modes maysimply be based on user preference as indicated, for example, via userinterface 435 of display device 910, 910′. Transitioning betweenoperation modes may involve sending a mode command.

As another example, system 900 may transition from medicament deliverymode to hybrid mode if the user is switching/replacing medicamentdelivery device 915 a. To illustrate, if the user's insulin pump isbroken or otherwise needs to be replaced, the user may manually initiatea transition from medicament delivery mode to hybrid mode beforedisengaging the insulin pump. In this manner, even when the insulin pumpis removed, display devices 910, 910′ may continue to receive analytedata from analyte sensor system 308 and provide such data to the user.Then, once the replacement insulin pump is installed, the system maytransition back to medicament delivery mode. The transition back to themedicament delivery mode may occur automatically, without userintervention, for example in response to analyte sensor system 308detecting a connection request from the replacement insulin pump. Inthis situation, it may not be necessary to transition to the displayoperating mode when the insulin pump is removed, because of therelatively short time during which the insulin pump is expected to beout of commission.

In embodiments, one or more display devices 910, 910′ may recommend tothe user that the operating mode be transitioned. For example, thepresence of medicament delivery device 915 a may be detected by analytesensor system 308 (e.g., via a connection request) and/or one or moredisplay devices 910, 910′, and as a result, a recommendation may beprovided to the user to transition to the medicament delivery or hybridoperating mode. In embodiments, such transitions may be triggered and/oroccur automatically upon detecting the presence and/or systemrequirements 650 or medicament delivery device 915 a. For example,system requirements 650 of medicament delivery device 915 a may beshared with analyte sensor system 308 and/or display devices 910, 910′,and upon parsing system requirements 650, it may be determined that aparticular operating mode (e.g., medicament delivery mode) is necessaryto accommodate system requirements 650 or that a particular operatingmode may be more suitable. Transition schemes between operating modesfor various scenarios may in embodiments be pre-programmed to defaultconfigurations, any of which be implemented.

A specific example of transitioning among operating modes will now beprovided. In this specific example, system 900 has been operating indisplay operating mode, with the user monitoring analyte data via mobilephone 910 a. In this example, a direct connection between medicamentdelivery device 915 a and analyte sensor system 308 will be established(e.g., using link 906 d). On mobile phone 910 a, the user may enable themedicament delivery operating mode, for example, in anticipation ofsetting up medicament delivery device 915 a. In response, mobile phone910 a may signal a mode switch to analyte sensor system 308 (e.g., usinglink 906 g). A connection may then be established between analyte sensorsystem 308 and medicament delivery device 915 a (e.g., by the processdescribed in connection with FIG. 7A or FIG. 7B). In some cases, mobilephone 910 a may remain connected to analyte sensor system 308. This mayprovide redundancy during the transition process.

Medicament delivery device 915 a may then use DMPI 750 to set/modifyconfiguration parameters 520 in accordance with system requirements 650.For example, medicament delivery device 915 a may provide systemrequirements 650 to analyte sensor system 308 so that analyte sensorsystem 308 can modify configuration parameters 520. Additionalinformation may be assessed in setting the configuration parameters 520,including for example, an age off time for medicament delivery device915 a, how long a sensor session will last (e.g., to coincide withinsulin alerts), and the types of alerts that will be used and how theywill propagate and be acknowledge through PAN 902/WAN 904. Uponterminating the use of medicament delivery device 915 a, the user can soindicate via mobile phone 910 a, such that mobile phone 910 a sendanother mode switch signal to analyte sensor system 308 to removemedicament delivery device 915 a from the whitelist and modifyconfiguration parameters 520 to revert to their previous values. Theabove example may be modified such that medicament delivery device 915 adoes not directly connect to analyte sensor system 308 but ratherconnects thereto via mobile phone 910 a via links 916 and 906 g. Itshould also appreciated that mode switches can generally be employed inan adaptive manner and/or based on user input, in order to accommodatechanges to the configuration of system 900, including for examplechanges relating to what devices are connectable to analyte sensorsystem 308 and/or are present within PAN 902 and/or WAN 904.

At this juncture, embodiments of methods and features that may beimplemented in connection with FIG. 9A and operating modes that may beimplemented in relation thereto (by way of example) will now bedescribed with reference, by way of example to FIGS. 9G, 9H, and 9Lthrough 9S. FIG. 9G is an operational flow diagram illustrating variousoperations that may be implemented, for example, by elements shown inFIG. 9A. FIG. 9G shows operations 950A through 950M that may beimplemented in connection with embodiments of method 948, where method948 may involve using DMPI 750 (with reference by way of example to FIG.10A) four analyte sensor system 3082 control wireless communicationsamong analyte sensor system 308 and one or more remote devicesconnectable to analyte sensor system 308, where the one or more remotedevices include one of display devices 910, 910′ and one of partnerdevices 915. For purposes of illustration only, reference will be madeto FIG. 9A and, for display devices 910, 910′, mobile phone 910 a willbe referenced for the one display device 910, 910′, and for partnerdevices 915, medicament delivery device 915 a will be referenced forpartner devices 915, unless noted otherwise. It should be appreciated,however that these specific examples of display devices 910, 910′ andpartner devices 915 are nonlimiting as to the scope of the presentdisclosure. The operations of method 948 may be used advantageously toimplement a flexible and adaptable system wherein different partnerdevices from different manufacturers may be accommodated through the useof a configurable diabetes management partner interface, including forexample to implement various operating modes, as described herein.

As shown in FIG. 9G, method 948 includes at operation 950A analytesensor system 308 determining whether a connection request received fromone of the remote devices originated from a partner class within the oneor more remote devices. In the context of method 948, the remote devicesin the partner class are adapted to provide medicaments. The partnerclass includes medicament delivery device 915 a.

At operation 950B, if the connection request originated from the partnerclass, then method 948 includes DMPI 750 enabling selection of anoperating mode corresponding to the partner class. In order to supportsystem requirements 650 of medicament delivery device 915 a (for examplereferencing FIG. 5B), the operating mode corresponding to the partnerclass uses a set of configuration parameters 520 (for examplereferencing FIG. 3C) for the partner class. The set of configurationparameters 520 are maintained within analyte sensor system 308.

At operation 950C, method 948 optionally includes exchanging thewireless communications with at least one of the remote devices usingthe operating mode corresponding to the partner class (e.g., any ofdisplay devices 910, 910′ and/or partner devices 915). FIG. 9H showsadditional operations that may be carried out in connection withoperation 950C of method 948, according to certain embodiments. Forexample, at operation 954A, exchanging the wireless communications usingthe operating mode corresponding to the partner class per operation 950Cmay include transmitting a mode indicator usable by the at least one ofthe remote devices to determine the operating mode is selected byanalyte delivery device 308. That is a mode indicator may be sent byanalyte sensor system 308 to connectable devices within range to conveyto such devices the operating mode being employed in connection with theuse of analyte sensor system 308.

As mentioned above, the set of configuration parameters 520 that may beused to support system requirements 650 of medicament delivery device915 a (again, by way of example) may include one or more of accesscontrol parameters for mobile phone 910 a or medicament delivery device915 a, accuracy or calibration parameters for analyte sensor system 308and wireless communication parameters for communications to be exchangedamong analyte sensor system 308 and one or more of the remote devices.In embodiments, the mode indicator referenced in connection withoperation 954A is operable by analyte sensor system 308 to use DMPI 750to deactivate access by a set of the remote devices that are not in thepartner class to one or more of the access control parameters, theaccuracy or calibration parameters, and the wireless communicationparameters. Additionally, in embodiments access to these parameters bythe set of the remote devices that are not in the partner class isactivated when analyte sensor system 308 uses an operating modecorresponding to the set of remote devices not in the partner class.

With further reference to FIG. 9H, operation 954B involves modifying awhite list maintained for analyte sensor system 308 in order to switchoff slots for devices other than medicament delivery device 915 a. Thatis, for example according to operation 954B, devices other thanmedicament delivery device 915 a may be prevented from receiving and/orresponding to advertisement messages transmitted by analyte sensorsystem 308. Operation 954C involves transmitting advertisement messagesdirected to only medicament delivery device 915 a or partner devicecontroller 645 (for example referencing FIG. 5B) that may be used inconjunction with medicament delivery device 915 a. For example operation954C may involve employing device-specific advertising. Alternatively oradditionally, operation 954C may involve analyte sensor system 308rejecting connection requests received in response to transmittedadvertisement messages, where such connection requests are received fromdevices other than medicament delivery device 915 a. In embodiments,operation 950C may include at operation 954D, responsive to a commandreceived via DMPI 750, analyte sensor system 308 accepting connectionrequest received from medicament delivery device 915 a only. By way ofexample, a user of analyte sensor system 308 may specify (for example,using user interface 435) that only medicament delivery device 915 a maycommunicate with analyte sensor system 308. As such, analyte sensorsystem 308 may be adapted to disregard connection requests that do notoriginate with medicament delivery device 915 a.

Referring again to FIG. 9G, if at operation 950A it is determined thatthe connection requests did not originate from the partner class, method948 optionally includes at operation 950D analyte sensor system 308selecting an operation mode corresponding to a set of the remote devicesthat are not in the partner class. The operating mode corresponding tothe set of the remote devices that are not in the partner class uses aset of configuration parameters 520 specific to the set of remotedevices that are not in the partner class. That is, for example DMPI 750may be used to adaptively configure the operation of analyte sensorsystem 308 and/or remote devices within system 900, such as for exampledisplay devices 910, 910′ based on an assessment that the connectionrequest was not received from partner devices 915. This may beadvantageous, for example, for the reasons above described above withrespect to certain partner devices 915, such as for example insulinpumps 915 b and 915 c, that potentially have less robust algorithms orother system requirements 650 that may not be operate optimally in anenvironment that includes interference from other remote devices.

Where mobile phone 910 a is in the set of remote devices that are not inthe partner class, embodiments of method 948 include at operation 950Eusing DMPI 750 to provide mobile phone 910 a with access to the set ofconfiguration parameters 520 specific to the set of remote devices thatare not in the partner class. In some such embodiments, method 948further includes at operation 950F analyte sensor system 308 setting ormodifying a value for one of the set of configuration parameters 520specific to the set of remote devices that are not in the partner class,responsive to input received from mobile phone 910 a. That is forexample according to an operating mode that may be employed wherepartner devices 915 are not communicating with analyte sensor system308, other remote devices may be enabled to more freely configurecertain characteristics of analyte sensor system 308 as may befacilitated using configuration parameters 520.

At operation 950G, method 948 optionally includes determining thatanalyte sensor system 308 has not received a wireless communication frommedicament delivery device 915 a for at least a predetermined amount oftime. In response to such a determination, and further in response toreceiving a connection request from one of the remote devices in a setof the remote devices that are not in the partner class, at operation950H, method 948 may include analyte sensor system 308 selecting anoperating mode corresponding to the set of the remote devices that arenot in the partner class. The operating mode corresponding to the set ofremote devices that are not in the partner class may follow a set ofconfiguration parameters 520 specific to the set of remote devices. Thatis, for example, according to an operating mode that may be employedwhere medicament delivery device 915 a has not communicated with analytesensor system 308 for a certain amount of time, which may bepredetermined, programmable, adaptable, and/or variable, analyte sensorsystem 308 may be adapted to employ an operating mode more tailored todisplay devices 910, 910′, as opposed to being more tailored tomedicament delivery device 915 a. In this manner, the flexibility ofsystem 900 enabled by DMPI 750 can enable system 900 to adapt andoptimize according to what devices are being used in PAN 902 and/or WAN904. Additionally, at operation 950J, medicament delivery device 915 jmay be removed from a whitelist for example that may be maintained foranalyte sensor system 308. In some cases, it may be advantageous toremove medicament delivery device 915 a from the whitelist if it isdetermined that medicament delivery device 915 a is not communicatingwith analyte sensor system 308, for example to allow other devices to bewhitelisted in the case that the whitelist caps the number of devicesthat may be whitelisted.

Embodiments of method 948 optionally includes at operation 950K analytesensor system 308 using DMPI 750 to receive from medicament deliverydevice 915 a a value for one of the set of configuration parameters 520.For example this value may be passed from medicament delivery device 915a to analyte sensor system 308 using link 906 d. Method 948 mayadditionally include at operation 950L analyte sensor system 308modifying the one configuration parameter 520 using the value receivedfrom medicament delivery device 915 a. At operation 950M, method 948 mayinclude analyte sensor system 308 sending the value for the oneconfiguration parameter 520 to mobile phone 910 a, for example usinglink 906 g. The value may include one or more of a specified time afterwhich medicament delivery device 915 a is to be removed from a whitelistmaintained for analyte sensor system 308, and a specified time afterwhich mobile phone 910 a is to be removed from the whitelist. In thismanner the user of mobile phone 910 a can be apprised of age off timesfor medicament delivery device 915 a and/or mobile phone 910 a, orindeed any other remote device shown in system 900.

FIG. 9L is an operational flow diagram illustrating various operationsthat may be implemented, for example, by elements shown in FIG. 9A. FIG.9L shows operations 958A through 958C that may be implemented inconnection with embodiments of method 956, where method 956 may involveusing DMPI 750 (with reference by way of example to FIG. 10A) to allowconfigurability of analyte sensor system 308 that exchanges wirelesscommunications with partner devices 915 and/or display devices 910, 910′(referencing FIG. 9A, for example). For purposes of illustration only,where appropriate, reference will be made to FIG. 9A and, for displaydevices 910, 910′, mobile phone 910 a, and for partner devices 915,medicament delivery device 915 a. It should be appreciated, however thatthese specific examples of display devices 910, 910′ and partner devices915 are nonlimiting as to the scope of the present disclosure. Theoperations of method 956 may be used advantageously to implement aflexible and adaptable system wherein different partner devices fromdifferent manufacturers may be accommodated through the use of aconfigurable diabetes management partner interface, including forexample to implement various operating modes, as described herein.

As shown in FIG. 9L, method 956 includes at operation 958A analytesensor system 308 determining that a first connection request was sentfrom a remote device in a first class of remote devices. The first classof remote devices may encompass display devices 910, 910′. Thus, forexample, the remote device in the first class of remote devices may bemobile phone 910 a that can use link 906 g to communicate with analytesensor system 308. At operation 958B, method 956 includes analyte sensorsystem 308 determining that a second connection request was sent from aremote device in a second class of remote devices. The remote devices ofthe second class of remote devices are adapted to deliver medicaments touser. Thus, for example, the remote device in the second class of remotedevices may be medicament delivery device 915 a. The first class ofremote devices in the second class of remote devices may be defined suchthat none of the remote devices of the first class of remote devicesbelongs to the second class of remote devices and vice versa.

At operation 958C, method 956 includes analyte sensor system 308 usinganyone of a plurality of operating modes. Various operating modes haveor will be discussed herein, and in embodiments such operating modes maybe used in connection with operation 958C. But, for purposes ofillustration, specific operating modes will now be discussed inconnection with embodiments of method 956 and more specificallyoperation 958C. According to operation 958C, a first operating mode ofthe plurality of operating modes is specific to a first configurationthat utilizes a remote device in the second class of remote devices anddoes not utilize a remote device in the first class of remote devices.As such, under the first configuration, medicament delivery device 915 ais connected/connecting to analyte sensor system 308 but mobile phone910 a is not connected/connecting to analyte sensor system 308. A secondoperating mode of the plurality of operating modes that may be used inconnection with operation 958C is specific to a second configurationthat does not utilize a remote device in the second class of remotedevices. As such, under the second configuration, mobile phone 910 a isconnected/connecting to analyte sensor system 308 but neither medicamentdelivery device 915 a nor any other partner device 915 adapted todeliver medicaments two user is connected/connecting to analyte sensorsystem 308. A third operating mode of the plurality of operating modesthat may be used in connection with operation 958C is specific to athird configuration that utilizes a remote device in the first class ofremote devices and a remote device from the second class of remotedevices. As such under the third configuration, both medicament deliverydevice 915 a and mobile phone 910 a are connected/connecting to analytesensor system 308.

FIGS. 9M, 9R, and 9S show additional operations that may be carried outin connection with operation 958C of method 956, according to certainembodiments. For example, as shown in FIG. 9M, where operation 958Cinvolves using the first operating mode of the plurality of operatingmodes, operation 958C may include at operation 962A providing the remotedevice and the second class of remote devices authority to use DMPI 750to modify permissions provided to the remote device in the first classof remote devices. By way of example, medicament delivery device 915 amay receive authorization to modify configuration parameters 520 usingDMPI 750, and more specifically such configuration parameters 520related to permissions. In example embodiments, the permissions may bemodified in order allow medicament delivery device 915 a to restrictmobile device 910 a's ability to control analyte data parameters (e.g.,such as accuracy or calibration parameters) four analyte sensor system308.

With further reference to FIG. 9M, where operation 958C involves usingthe first operating mode of the plurality of operating modes, operation958C may include at operation 962B analyte sensor system 308 receivingfrom the remote device in the first class of remote devices andauthentication for the remote device in the second class of remotedevices to communicate with analyte sensor system 308. For example, auser may authenticate medicament delivery device 915 a for communicationwith analyte sensor system 308, where the user grants authentication viamobile phone 910 a. Additionally, where operation 958C involves usingthe first operating mode of the plurality of operating modes, operation958C optionally includes at operation 962C, responsive to input receivedvia DMPI 750 from the remote device in the second class of remotedevices, analyte sensor system 308 preventing a connection with devicesother than the remote device in the second class of remote devices.Thus, for example, management delivery device 915 a may use DMPI 752configure analyte sensor system 308 such that only medicament deliverydevice 915 a is connectable to analyte sensor system 308.

FIGS. 9N, 9P, and 9Q show additional operations that may be carried outin connection with operation 962C of method 956, according to certainembodiments. For example, FIG. 9N shows that operation 962C (preventingthe connection with devices other than the remote device in the secondclass of remote devices) may include at operation 966A using a firstadvertisement slot to advertise to the remote device in the second classof remote devices and may further include at operation 966B using asecond advertisement slot to advertise to the remote device in thesecond class of remote devices or a controller for the remote device inthe second class of remote devices (for example, partner devicecontroller 645, referencing FIG. 5B). In this manner, all availableadvertisement slots or durations may be used to advertise for medicamentdelivery device 915 a, such that there may be no opportunity foradvertising to other remote devices such as, for example, displaydevices 910, 910′.

FIG. 9P shows that operation 962C (preventing the connection withdevices other than the remote device in the second class of remotedevices) may include at operation 970 analyte sensor system 308 usingDMPI 750 to set or cause a modification to advertisement structure 622(referencing, for example, FIG. 6) to include a single advertisementduration 614 that may be dedicated to the remote device and the secondclass of remote devices. As such, in embodiments, DMPI 750 may be usedto set/modify configuration parameters 520 such that advertisementstructure 622 includes only one advertisement slot, and thatadvertisement slot is used to advertise to medicament delivery device915 a. In this manner the remote devices such as, for example, displaydevices 910, 910′ may be prevented from connecting with analyte sensorsystem 308, thus supporting the first operating mode according toexample implementations.

FIG. 9Q shows that operation 962C (preventing the connection withdevices other than the remote device in the second class of remotedevices) may include at operation 974 analyte sensor system 308accepting connection requests from only the remote device in the secondclass remote devices. That is, one example of how remote devices otherthan devices adapted to deliver medicaments to users may be preventedfrom connecting to analyte sensor system 308 involves rejectingconnection requests that do not originate from devices adapted todeliver medicaments to users. In embodiments, one or more packets sentto analyte sensor system 308 with a connection request may identifywhether or not the device sending such packets is adapted to delivermedicaments such that analyte sensor system 308 may parse the packet(s)to determine what type of device the packet, and hence in this examplethe connection request, originated from.

Referring back to FIG. 9M, at operation 962D, where operation 958Cinvolves using the first operating mode of the plurality of operatingmodes, operation 958C optionally includes analyte sensor system 308using input received from the remote device in the second class ofremote devices via DMPI 750 to modify timeout rules associated with theremote device in the second class of remote devices. For example,medicament delivery device 915 a may use DMPI 750 to modifyconfiguration parameters 520 and modify timeout settings for medicamentdelivery device 915 a or for that matter for display devices 910, 910′as well.

Now referencing FIG. 9R, additional operations that may be carried outin connection with operation 958C of method 956 (analyte sensor system308 using any one of the plurality of operating modes) will now bediscussed, according to certain embodiments. More specifically, FIG. 9Rillustrates operations that may be carried out in connection withanalyte sensor system 308 using the second operating mode of theplurality of operating modes. For example using the second operatingmode, in embodiments, includes one or more of modifying a whitelist toexclude the remote device in the second class of remote devices (forexample, at operation 978A), rejecting connection requests received fromthe remote device in the second class of remote devices (for example, atoperation 978B), and advertising exclusively for remote devices in thefirst class of remote devices (for example, at operation 978C). Each ofthese operations may be used to prevent devices adapted to delivermedicaments to users from connecting to analyte sensor system 308.

FIG. 9S illustrates additional options operations that may beimplemented according to embodiments of operation 958C (analyte sensorsystem 308 using any one of the plurality of operating modes). Morespecifically, FIG. 9S shows example operations that may be performed inconnection with analyte sensor system 308 using the third operating modeof the plurality of operating modes. In the third operating mode of theplurality, display devices 910, 910′ may receive and/or present analytedata, but may not have the ability to issue control/command signals thatanalyte sensor system 308 will implement, for example where suchcontrol/command signals relate to the generation of analyte data. Insome cases, this version of the third operating mode may be referred toherein as a display only operating mode.

At operation 982A, operation 958C optionally includes analyte sensorsystem 308 receiving, via DMPI 750, an indication from the remote devicein the second class of remote devices of a level of access to analytesensor system 308 that the remote device in the first class of remotedevices is to be given. For example medicament delivery device 915 a mayuse DMPI 750 to access configuration parameters 520 and thereby manageif and how other remote devices such as display devices 910, 910′ canconnect within system 900, and in some cases specifically to analytesensor system 308, and/or what level of control or access such remotedevices may have within system 900, including for example what level ofcontrol/access may be available to analyte sensor system 308. Atoperation 982B, operation 958C may include analyte sensor system 308using DMPI 750 to implement the level of access to analyte sensor system308. At operation 982C, operation 958C optionally includes notifying theremote device in the first class of remote devices of the level ofaccess. That is, for example mobile phone 910 a and/or user thereof maybe notified of how medicament delivery device 915 a is managing thelevel of control provided to mobile device 910 a. In embodiments,according to the level of access, the remote device in the first classof remote devices can receive analyte data from analyte sensor system308 but cannot access accuracy or calibration parameters withinconfiguration parameters 520 used by analyte sensor system 308 for thethird operating mode. That is, for example, medicament delivery device915 a can use DMPI 750 to put this play devices 910, 910′ into displayonly mode by altering permissions granted to display devices 910, 910′(e.g., mobile phone and 910 a).

In connection with the above-described operating modes that may be usedin embodiments of system 900, and with reference to FIGS. 4 and 5B, oneor more of analyte sensor application 425 a, partner device application425 b, and medicament delivery application 625 may provide a user withinformation regarding the operating mode being employed as well asfurther information related to the operating mode and implicationsregarding system 900. By way of example, analyte sensor systemapplication 425 a may obtain or track information regarding which of themedicament delivery, display, or hybrid operating modes is being used.As such, analyte sensor application 425 a may present information to theuser via user interface 435 that system 900 is operating in themedicament delivery operating mode. Analyte sensor application 425 a mayfurther provide information indicating that analyte sensor system 308 isin range and connectable to one or more display devices 910, 910′, butthat, as a result of system 900 being in medicament delivery operatingmode, analyte sensor system 308 is not exchanging analyte data with suchdisplay devices 910, 910′.

In some cases, system 900 may rely on information stored, for example inanalyte sensor system 308 (storage 515), display device 310 (storage415), partner device 315 (storage 615), and/or server system 334(storage 334 b) to determine aspects of operation, such as the operatingmode to be used under certain conditions, as well as authenticating andpairing remote devices. For example, a database, table, or other formatof information may provide a list of authorized partner devices 915,including medicament delivery devices 915 a (e.g., based onidentification numbers for each device) and respective operating modesthat each such partner devices 915 may support, may provide informationregarding authenticating and pairing the partner devices, etc. In somecases, the stored information can act as a master directory of systemrequirements for a universe of partner devices 915. Such a masterdirector may be maintained in server system 334 for example. Selectinformation may then be downloaded to analyte sensor system 308 if, forexample, particular partner devices 915 may be employed in system 900.

With respect to operating modes more generally as described herein, whentransitioning among connection modes, connection modes may need to bechanged as well. For example, for operating in display operating mode,two display devices 910, 910′ may employ the continuous connectionmodel. If medicament delivery device 915 a is activated, however, andthe operating mode is transitioned to medicament delivery mode, forexample, the continuous connection model may be employed as betweenmedicament delivery device 915 a while display devices 910, 910′ may usethe intermittent connection model (e.g., per communication session 720)and/or the advertisement broadcast mode (e.g., per communication session760).

L. Application Integration & Interfaces

With reference to FIG. 9A, and as discussed in connection withembodiments of the present disclosure, in some cases, a user may beusing analyte sensor system 308 and also medicament delivery device 915a (e.g., an insulin pump). In embodiments, elements of the user's PAN902 may be in connection to remote cloud services, for example providedvia WAN 904. In embodiments analyte sensor application 425 a(referencing FIG. 4 by way of example) may act as the primary gatewayfor the user to interact with system 900. Medicament delivery device 915a may have an application running locally thereon (e.g., medicamentdelivery application 625, referencing FIG. 5B), such that medicamentdelivery application 625 acts as a secondary gateway for the user tointeract with system 900. In some cases, analyte sensor system 308 mayemploy the intermittent connection model or another connection modeldiscussed herein to share analyte data with analyte sensor application425 a and medicament delivery device 915 a periodically. Additionally,medicament delivery device 915 a may share medicament-related data withapplication 425, for example periodically per the intermittentconnection model or using another connection model discussed herein.

It should be appreciated, however, that as between analyte sensor system308 and analyte sensor application 425 a/medicament delivery device 915a, on the one hand, and medicament delivery device 915 a and analytesensor application 425 a, on the other hand, different connection modelsand advertisement structures may be employed. As such, inconsistenciesmay arise in the information that is provided via analyte sensorapplication 425 a and medicament delivery application 625.

Accordingly, embodiments of the present disclosure include anintegrative interface to share data between partner devices 915 anddisplay devices 910, 910′ within system 900. In some cases, thisintegrative interface is particularly useful when system 900 isoperating in the hybrid operating mode described above. Coordinatedsharing of information between display devices 910, 910′ and partnerdevices 915 (e.g., medicament delivery device 915 a) can improve insulinvisualization, for example, including by providing enriched informationsuch as alerts related to the working status of display devices 910,910′ and/or partner devices 915 and the like. In embodiments, theintegrative interface is implemented as part of DMPI 750 (referencingFIG. 10A).

In embodiments, the integrative interface facilitates communications andthe exchange of information between applications running on differentdevices within system 900. For example, and with reference to FIGS. 4and 5B, analyte sensor application 425 a that may run on mobile phone910 a may use such an integrative interface to communicate and exchangeinformation with partner device application 425 b and/or medicamentdelivery application 625 running on medicament delivery device 915 a. Inembodiments, analyte sensor application 425 a may obtain (e.g., downloadand/or install) this interface from server system 334 b (e.g., as may bemaintained or serviced by the manufacturer of analyte sensor system 308,the provider of analyte sensor application 425 a, the manufacturer ofmedicament delivery device 915 a, and/or the provider of partner deviceapplication 425 b or medicament delivery application 625), from anotherremote location (including, e.g., an app store or the like), or frommedicament delivery device 915 a.

Analyte sensor application 425 a may then obtain information frommedicament delivery device 915 a or medicament delivery application 625running thereon, including from or by way of partner device application425 b. Such information may include pairing/bonding data exchangedbetween analyte sensor system 308 and medicament delivery device 915 a,historical data relating to medicament (e.g., insulin) dosage and thelike provided by medicament delivery device 915 a, or other information(e.g., user preferences for medicament delivery device 915 a, medicalinformation, alert information, etc.). Also, for example, alertinformation may be provided by partner device application 425 b,medicament delivery application 625, and/or medicament delivery device915 a to analyte sensor application 425 a, such that analyte sensorapplication 425 a can then pass the alert information to the user. Inthis manner, alert information can essentially be funneled to the userand/or other systems or individuals monitoring the user, in acoordinated way, thus assisting in preventing the user from beingbombarded by too many alerts from too many different (and in some casesoverly redundant) sources. That is, analyte sensor application 425 a mayact as a hub for alerts stemming from different elements of system 900,and may control the propagation and distribution, as well as theescalation and acknowledgement processes associated with alerts, whethersuch alerts are related to analyte data or insulin data etc.

In addition, analyte sensor application 425 a may be used to provideinformation to partner device application 425 b, medicament deliveryapplication 625, and/or medicament delivery device 915 a. By way ofexample, such information may relate to analyte sensor system 308,including a working status thereof, mode of operation being employed,historical data relating to system operation, user preferences and otheruser-related information (e.g., other remote devices used for healthmanagement), and so forth. In some cases, certain data (e.g., analyte orEGV data etc.) may not be shared with partner device application 425 b,medicament delivery application 625, and/or medicament delivery device915 a, for example where sharing such information would subject system900 to regulations that may result in partner device application 425 b,medicament delivery application 625, and/or medicament delivery device915 a, etc. being classified as a class 3 medical device. In othercases, however, such data may be shared.

In terms of communications between/among analyte sensor application 425a, partner device application 425 b, and/or medicament deliveryapplication 625 (referencing FIGS. 4 and 5B, for example), theseapplications can be linked together once they are obtained andinstalled. For example, a user may download one or more of theseapplications, and navigate through analyte sensor application 425 ausing user interface 435 to select another application for linking(e.g., partner device application 425 b and/or medicament deliveryapplication 625). For example, a particular menu of application 425 amay be dedicated to linking with applications associated with partnerdevices 915 (e.g., applications 425 b or 625). In embodiments, theapplications may be linked automatically upon installation (with orwithout user approval, depending on the implementation), according toconfiguration(s)/settings that may be predetermined by the provider ofanalyte sensor application 425 a, partner device application 425 band/or medicament delivery application 625.

Communications between/among analyte sensor application 425 a, partnerdevice application 425 b, and/or medicament delivery application 625 mayalso be facilitated using remote services provided via server 920 b. Byway of illustration, medicament-related information and/or alertsstemming from medicament delivery device 915 a may be uploaded to server920 b and then downloaded, for example, via analyte sensor application425 a running on mobile phone 910 a (which, e.g., may belong to a userof analyte sensor system 308 or another individual monitoring the user'sanalyte data).

In embodiments, server(s) 920 b maintained by a manufacturer of analytesensor system 308 and/or provider of analyte sensor application 425 amay include database of partner device applications 425 b and/ormedicament delivery applications 625 associated with manufacturers ofpartner devices 915 and/or providers of partner device applications 425b and/or medicament delivery applications 625. In this manner, therelevant application 425 b, 625 may be obtained from server 920 b oncethe manufacturer/provider is identified (e.g., using identificationinformation exchanged during or after pairing between analyte sensorsystem 308 and medicament delivery device 915 a).

It should also be appreciated that in embodiments, medicament deliveryapplication 625 may have the interface and/or capability to communicatedirectly with medicament delivery device 915 a only, and not withanalyte sensor application 425 a or analyte sensor system 308. In somesuch embodiments, medicament delivery device 915 a may not includemedicament delivery application 625, but instead medicament deliverydevice 915 a may use partner device 425 a running on mobile phone 910 aand/or medicament delivery application 625 may run on partner devicecontroller 645, for example. Thus, in example implementations,medicament delivery device 915 a may receive information, including forexample analyte data, EGV data, sensor data, etc., from analyte sensorsystem 308 and provide this information to medicament deliveryapplication that is running on partner device controller 645.

In example implementations, partner device controller 645 that may beused in conjunction with medicament delivery device 915 a may providewireless connectivity to medicament delivery 915 a (e.g., in some cases,medicament delivery device 915 a may not include connectivity interface605, which instead may be included in partner device controller 645).

In embodiments, the user may be provided (e.g., via analyte sensorapplication 425 a, partner device application 425 b, and/or medicamentdelivery application 625) the ability to implement a tradeoff betweenconvenience and safety/accuracy regarding analyte data and the provisionof medicaments, at least to a degree. For example, the user may beprovided a degree of control over how expected/needed calibrations toanalyte sensor system 308 may be alerted in the context of system 900.Features may thus be provided in accordance with embodiments to enablethe user to flexibly strike a balance between care, safety, or qualityof diabetes management, on the one hand, and convenience nuisance, andcontrol/level of user interaction on the other hand. In exampleimplementations, a sliding scale concept may enable the user to selectdifferent pre-set configurations of various configuration parameters 520that can be used to govern accuracy, calibration, power management, aswell as alerts. In certain situations, the user may, for conveniencepurposes, want to enable some flexibility in terms of the user's bloodglucose levels, for example if the user has an important meeting orother event, the user may want to disable alerts or periodiccalibrations. Configuration parameters 520 can be pre-set for suchoccasion, for example into modes that the user may select accordingly(e.g., meeting mode). It should be appreciated, however, that safety mayrequire limitations on the degree of flexibility that a user may beprovided. Such safety limitations may be user-specific, based on theuser's medical information, profile, or data gathered over time.

With further reference to FIG. 9A by way of example, embodiments relatedto setting up implementations of system 900 that include display devices910, 910′ as well as partner devices 915 used for the delivery ofmedicaments, such as for example medicament delivery device 915 a, willnow be described. Such implementations of system 900 may includedifferent devices from different manufacturers that are intended tointerconnect and interoperate, and it may be advantageous to provide aneasy and flexible set up procedure.

Accordingly, embodiments of the present disclosure are directed tofacilitating the set up and initial configuration of suchimplementations of system 900. Some such embodiments include anintegrated out-of-the-box experience, such that at least from the user'sperspective, medicament delivery device 915 a and analyte sensor system308 and/or analyte sensor application 425 a appear to be intended towork together. That is, for such embodiments, the set up process shouldbe configured so that it does not feel like an assembly of unrelatedparts. For example, a similar pairing process may be used as betweendisplay devices 910, 910′ and analyte sensor system 308, on the onehand, and medicament delivery device 915 a and analyte sensor system308, on the other hand.

In embodiments, the user may be provided the option to arrange the orderof setting up various devices within system 900. For example, the usermay choose to first set up analyte sensor application 425 a, thenpartner device application 425 b and/or medicament delivery device 625,or vice versa. Additionally, in some cases the user may be able toselect an option wherein applications for 425 a and 425 b areessentially merged into a single application that includes both theanalyte data related features and the medicament delivery data features.In embodiments, the single application option may be enabled/facilitatedby DMPI 750. The single application, as a merge of applications 425 aand 425 b may involve an integration of all the features offered by eachapplication 425 a and 425 b. Using this option may streamline the set upprocess, since only a single application will be used.

In one example this single application option may be accomplished by theprovider of analyte sensor application 425 a providing a software designkit, including for example all the building blocks/features of analytesensor application 425 a, to a manufacturer of partner device 915 (e.g.,medicament delivery device 915 a) and/or the provider of partner deviceapplication 425 b or medicament delivery application 625. In thismanner, the provider may use the software design kit to incorporate thefeatures of analyte sensor application 425 a into partner deviceapplication 425 b or medicament delivery application 625. Inembodiments, the provider of analyte sensor system 308 and/or analytesensor application 425 a may maintain a database of analyte data relatedfeatures (e.g., any feature implemented in connection with analytesensor system 308 and/or analyte sensor application 425 a), for examplein server 920 b (referencing FIG. 9A). The manufacturer of partnerdevice 915 (e.g., medicament delivery device 915 a) and/or the providerof partner device application 425 b or medicament delivery application625 may then access this database to obtain those software design kitfor any feature of interest (e.g., a trend feature foranalyzing/displaying a trend in analyte data values), provided that sucha feature is accessible (e.g., permissions may be implemented torestrict access to certain features). The software design kit may beobtained (for example, downloaded) and used two designed the relevantfeature into partner device application 425 b or medicament deliveryapplication 625.

Alternatively or additionally, the provider of partner device 915 (e.g.,medicament delivery device 915 a), partner device application 425 band/or medicament delivery application 625 may upload features relatedto partner device 915 (e.g., medicament delivery device 915 a), partnerdevice application 425 b and/or medicament delivery application 625 twoserver 920 b, for example. By way of illustration such features mayinclude an insulin visualization tool, or the like. Display device 910,910′ may then directly or indirectly access server 920 b to download thedesired feature for inclusion in, for example analyte sensor application425 b. In some cases the provider of analyte sensor application 425 bmay create modules for incorporating downloadable code for implementingsuch features or the like so that features can essentially beimplemented in a plug-and-play fashion, without requiring extensive userinteraction.

During the setup process, user interface 435, with reference to FIG. 4,may indicate the progress/status of the set up. Additionally, optionsmay be provided for the user to adapt the level of inter-activityinvolved in the setup process. For example, a power user may exercisethe option to assert more control over configuration during the setupprocess.

In some cases, the setup process may be streamlined where common set offeatures applied to a first device/application may be conveyed to asecond device/application, thus enabling such common aspects to bebypassed when the second device/application set up process occurs. Theset up for such common features may be conveyed among different devicesusing a mutual connection path or link within system 900, since in someinstances to devices may not be able to connect directly until after theset up process is completed. Here it should be noted that analyte sensorapplication 425 a may be able to use DMPI 752 access configurationparameters 520 and configure the same in accordance with systemrequirements 650 of medicament delivery device 915 a in response toinformation identifying medicament delivery device 915 a. By way ofexample and identification number or other identifying informationassociated with medicament delivery device 915 a may be used to identifypredetermined, customizable settings for medicament delivery device 915a, and these settings may be implemented my application 425 a using DMPI750 to modify or set configuration parameters 520 according to thesettings. Furthermore, such identifying information may be used toencrypt analyte data transmitted to medicament delivery device 915 aetc.

Additional embodiments concerning the integration of features acrosssystem 900 may involve, for example, features implemented in connectionwith services that may be provided via servers 920 b. Such services mayallow other individuals or entities, such as medical professionals,healthcare equipment, friends, and family, to monitor or follow a userwith respect to the user's analyte data and/or medicament data generatedusing analyte sensor system 308 and/or medicament delivery device 915 a.In this manner, for example the users blood glucose level or insulindelivery can be monitored by others, for safety purposes. In connectionwith this monitoring, alerts may be provided to those individuals orentities following the user.

With general reference by way of example to FIG. 9A and system 900, theuser may can figure what aspects of analyte data and/or medicament dataare exposed to the user's followers. In this connection, the user mayset different permissions for different followers, such that certainfollowers may be able to have greater access to certain data, and may beable to respond to alerts in different ways. In some cases, defaultpermissions may be implemented based on a category of the follower, forexample, friends and family may be defaulted to have a first set ofpermissions, caretakers may be defaulted to have a second set ofpermissions, and hospitals or doctors may be defaulted to have ⅓ set ofpermissions.

Another aspect of configuring permissions may use a type of device thatis performing the monitoring. By way of example, more restrictivepermissions may be set for a follower's television which is more widelyvisible to other people besides the follower, while less restrictivepermissions may be set for a follower's phone or computer. That is, inembodiments the user may customize permissions according to a desiredlevel of privacy. The permissions may also be set in an adaptable mannerusing location-based information such as whether the setting is privateor public, e.g., a restaurant versus a home. In some cases, thepermissions may be adaptively set based on the follower's time zone(e.g., if the time zone indicates that the follower might be asleep, thealert can be configured to wake up the follower). Yet another aspect ofconfiguring a follower's access to analyte and/or medicament data andassociated alerts may be related to the mode of the device used tofollow the user. For example a follower's device may be on silent orairplane mode or do not disturb, but in case of an emergency, asreflected by the analyte and/or medicament data and/or the alert itself,the device setting may be overridden and the alert providednotwithstanding that for example the device is in airplane mode.Additionally the follower's device, if it is in a mode where alerts arenot receivable, may so indicate such that for example an alternativemeans of notifying the follower may be attempted such alternative meansmay be an email alert or a landline call placed using the follower'sdevice location.

With further regard to services that may be provided via server 920 b,in embodiments the availability of access to server 920 b through WAN904 may serve as an input to setting or modifying configurationparameters 520 of analyte sensor system 308. For example analyte sensorsystem 308 may determine the availability of a connection, whetherdirect or indirect, to server 920 b (e.g., via mobile phone 910 a andcell network 920 c, router 920 a, etc.) in PAN 902. Using thedetermination, configuration parameters 520 may then be set/modified,for example, to configure the types of alerts that may be employedvis-à-vis analyte and/or medicament data. As cloud services increase inubiquity, the ability to adaptively utilize such services becomesincreasingly advantageous.

Some examples of services that may be provided via WAN 904, includingfor example servers 920 b, will now be discussed. As mentioned, aservice that may be provided via WAN 904 involves followers of a user ofanalyte sensor system 308. Such followers may utilize WAN 904 to connectan electronic device such as a smart phone, television, computer, andthe like to PAN 902 and thus receive relevant analyte, medicamentdelivery, and/or other information related to the use of analyte sensorsystem 308 and/or the use of medicament delivery device 915 a. Thefollower's electronic device may run an application specificallydesigned for following the user of analyte sensor system 308 and/ormedicament delivery device 915 a. This application may then be used onthe follower's electronic device to provide alerts, for example thevarious alerts described above, insulin values, insulin visualization,CGM values, trends, etc.

In embodiments, additional cloud services that may be provided via WAN904 may involve services provided to the user of analyte sensor system308 and/or medicament delivery device 915 a. By way of example, analytesensor application 425 a, partner device application 425 b, and/ormedicament delivery application 625 (referencing, for example, FIGS. 4,5B, 6) may provide web links to tutorials, help files, or videosrelating to the use and/or set up of analyte sensor system 308 ormedicament delivery device 915 a. Such tutorials, help files, or videosmay be provided by the respective manufacturers of analyte sensor system308 or medicament delivery device 915 a, or may be provided by others,for example other users.

Another example of a cloud service that may be provided via WAN 904 mayinvolve obtaining settings or system requirements 650 for medicamentdelivery device 915 a that may be specific to the user of system 900.Such settings or system requirements 650 may have been determined by theuser's healthcare provider, and may include, for example, one or more ofa basal infusion rate, insulin to carb ratio, and the like. Thesesettings or system requirements 650 may be communicated to the user viaWAN 904, and may, using DMPI 750, be used to set/modify configurationparameters 520 of analyte sensor system 308.

In one example, the healthcare provider may upload those settings orsystem requirements 650 to WAN 904. Subsequently, the user may accessthese settings or system requirements 650 via server 920 b, and candownload the settings or system requirements 650 for automaticimplementation via setting or modifying configure right patientparameters 520 (for example, the download may be direct from server 920b to analyte sensor system 308 or may utilize an intermediate deviceconnectable to WAN 904, such as for example mobile phone 910 a or otherdisplay device 910, 910′). In this particular example, server 920 b (orsoftware implemented in or in connection with server 920 b) mayperiodically (for example, weekly/monthly) gather information related tomedicament delivery and analyte data (e.g., insulin and glucose data).Server 920 b and/or software implemented in association there with maythen analyze the information and determine whether modifications tosettings, system requirements 650, and/or configuration parameters 520may be more effective for the user, including in some cases consideringthe user's lifestyle and/or health goals.

M. Additional Embodiments

One of skill in the art will appreciate upon studying the presentdisclosure that various additional embodiments not described explicitlyherein are within the spirit and scope of the present disclosure.

FIG. 11 illustrates example computing module 1100, which may in someinstances include a processor/microprocessor/controller resident on acomputer system (e.g., in connection with server system 334, any of thedisplay devices described herein (e.g., display devices 120, 130, 140,310(a, b, etc.), 910(a, b, etc.), partner devices 315(a, b, etc.),915(a, b, etc.), and/or analyte sensor system 8, 308, etc. Computingmodule 1100 may be used to implement various features and/orfunctionality of embodiments of the systems, devices, apparatuses, andmethods disclosed herein. With regard to the above-described embodimentsset forth herein in the context of systems, devices, apparatuses, andmethods described with reference to the various FIGS. of the presentdisclosure, including embodiments of analyte sensor system 308, displaydevice 310, 910, etc., partner devices 315, 915, etc., server system334, 334 a, 334 b, servers 920 b, and components of the foregoing asdescribed and/or contemplated herein, etc., one of skill in the art willappreciate upon studying the present disclosure the additionalvariations and details regarding the functionality of these embodimentsthat may be carried out by computing module 1100. In this connection, itwill also be appreciated by one of skill in the art upon studying thepresent disclosure that features and aspects of the various embodiments(e.g., systems, devices, and/or apparatuses, and the like) describedherein may be implemented with respected to other embodiments (e.g.,methods, processes, and/or operations, and the like) described hereinwithout departing from the scope or spirit of the disclosure.

As used herein, the term module may describe a given unit offunctionality that may be performed in accordance with one or moreembodiments of the present application. As used herein, a module may beimplemented utilizing any form of hardware, software, or a combinationthereof. For example, one or more processors, controllers, ASICs, PLAs,PALs, CPLDs, FPGAs, logical components, software routines or othermechanisms may be implemented to make up a module. In implementation,the various modules described herein may be implemented as discretemodules or the functions and features described may be shared in part orin total among one or more modules. In other words, as would be apparentto one of ordinary skill in the art after reading this description, thevarious features and functionality described herein may be implementedin any given application and may be implemented in one or more separateor shared modules in various combinations and permutations. Even thoughvarious features or elements of functionality may be individuallydescribed or claimed as separate modules, one of ordinary skill in theart will understand that these features and functionality may be sharedamong one or more common software and hardware elements, and suchdescription shall not require or imply that separate hardware orsoftware components are used to implement such features orfunctionality.

Where components or modules of the application are implemented in wholeor in part using software, in one embodiment, these software elementsmay be implemented to operate with a computing or processing modulecapable of carrying out the functionality described with respectthereto. One such example computing module is shown in FIG. 11. Variousembodiments are described in terms of example computing module 1100.After reading this description, it will become apparent to a personskilled in the relevant art how to implement the application using othercomputing modules or architectures.

Referring now to FIG. 11, computing module 1100 may represent, forexample, computing or processing capabilities found within mainframes,supercomputers, workstations or servers; desktop, laptop, notebook, ortablet computers; hand-held computing devices (tablets, PDA's,smartphones, cell phones, palmtops, etc.); other display devices,application-specific devices, or other electronic devices, and the like,depending on the application and/or environment for which computingmodule 1100 is specifically purposed.

Computing module 1100 may include, for example, one or more processors,microprocessors, controllers, control modules, or other processingdevices, such as a processor 1110, and such as may be included incircuitry 1105. Processor 1110 may be implemented using aspecial-purpose processing engine such as, for example, amicroprocessor, controller, or other control logic. In the illustratedexample, processor 1110 is connected to bus 1155 by way of circuitry1105, although any communication medium may be used to facilitateinteraction with other components of computing module 1100 or tocommunicate externally.

Computing module 1100 may also include one or more memory modules,simply referred to herein as main memory 1115. For example, randomaccess memory (RAM) or other dynamic memory may be used for storinginformation and instructions to be executed by processor 1110 orcircuitry 1105. Main memory 1115 may also be used for storing temporaryvariables or other intermediate information during execution ofinstructions to be executed by processor 1110 or circuitry 1105.Computing module 1100 may likewise include a read only memory (ROM) orother static storage device coupled to bus 1155 for storing staticinformation and instructions for processor 1110 or circuitry 1105.

Computing module 1100 may also include one or more various forms ofinformation storage devices 1120, which may include, for example, mediadrive 1130 and storage unit interface 1135. Media drive 1130 may includea drive or other mechanism to support fixed or removable storage media1125. For example, a hard disk drive, a floppy disk drive, a magnetictape drive, an optical disk drive, a CD or DVD drive (R or RW), or otherremovable or fixed media drive may be provided. Accordingly, removablestorage media 1125 may include, for example, a hard disk, a floppy disk,magnetic tape, cartridge, optical disk, a CD or DVD, or other fixed orremovable medium that is read by, written to or accessed by media drive1130. As these examples illustrate, removable storage media 1125 mayinclude a computer usable storage medium having stored therein computersoftware or data.

In alternative embodiments, information storage devices 1120 may includeother similar instrumentalities for allowing computer programs or otherinstructions or data to be loaded into computing module 1100. Suchinstrumentalities may include, for example, fixed or removable storageunit 1140 and storage unit interface 1135. Examples of such removablestorage units 1140 and storage unit interfaces 1135 may include aprogram cartridge and cartridge interface, a removable memory (forexample, a flash memory or other removable memory module) and memoryslot, a PCMCIA slot and card, and other fixed or removable storage units1140 and storage unit interfaces 1135 that allow software and data to betransferred from removable storage unit 1140 to computing module 1100.

Computing module 1100 may also include a communications interface 1150.Communications interface 1150 may be used to allow software and data tobe transferred between computing module 1100 and external devices.Examples of communications interface 1150 include a modem or softmodem,a network interface (such as an Ethernet, network interface card,WiMedia, IEEE 802.XX or other interface), a communications port (such asfor example, a USB port, IR port, RS232 port Bluetooth® interface, orother port), or other communications interface configured to operationwith the communication media described herein. Software and datatransferred via communications interface 1150 may in examples be carriedon signals, which may be electronic, electromagnetic (which includesoptical) or other signals capable of being exchanged by a givencommunications interface 1150. These signals may be provided to/fromcommunications interface 1150 via channel 1145. Channel 1145 may carrysignals and may be implemented using a wired or wireless communicationmedium. Some non-limiting examples of channel 1145 include a phone line,a cellular or other radio link, an RF link, an optical link, a networkinterface, a local or wide area network, and other wired or wirelesscommunications channels.

In this document, the terms “computer program medium” and “computerusable medium” and “computer readable medium”, as well as variationsthereof, are used to generally refer to transitory or non-transitorymedia such as, for example, main memory 1115, storage unit interface1135, removable storage media 1125, and/or channel 1145. These and othervarious forms of computer program media or computer usable/readablemedia may be involved in carrying one or more sequences of one or moreinstructions to a processing device for execution. Such instructionsembodied on the medium, may generally be referred to as “computerprogram code” or a “computer program product” or “instructions” (whichmay be grouped in the form of computer programs or other groupings).When executed, such instructions may enable the computing module 1100,circuitry related thereto, and/or a processor thereof or connectedthereto to perform features or functions of the present disclosure asdiscussed herein (for example, in connection with methods describedabove and/or in the claims), including for example when the same is/areincorporated into a system, apparatus, device and/or the like.

Various embodiments have been described with reference to specificexample features thereof. It will, however, be evident that variousmodifications and changes may be made thereto without departing from thebroader spirit and scope of the various embodiments as set forth in theappended claims. The specification and figures are, accordingly, to beregarded in an illustrative rather than a restrictive sense.

Although described above in terms of various example embodiments andimplementations, it should be understood that the various features,aspects and functionality described in one or more of the individualembodiments are not limited in their applicability to the particularembodiment with which they are described, but instead may be applied,alone or in various combinations, to one or more of the otherembodiments of the present application, whether or not such embodimentsare described and whether or not such features are presented as being apart of a described embodiment. Thus, the breadth and scope of thepresent application should not be limited by any of the above-describedexample embodiments.

Terms and phrases used in the present application, and variationsthereof, unless otherwise expressly stated, should be construed as openended as opposed to limiting. As examples of the foregoing: the term“including” should be read as meaning “including, without limitation” orthe like; the term “example” is used to provide illustrative instancesof the item in discussion, not an exhaustive or limiting list thereof;the terms “a” or “an” should be read as meaning “at least one,” “one ormore” or the like; the term “set” should be read to include one or moreobjects of the type included in the set; and adjectives such as“conventional,” “traditional,” “normal,” “standard,” “known” and termsof similar meaning should not be construed as limiting the itemdescribed to a given time period or to an item available as of a giventime, but instead should be read to encompass conventional, traditional,normal, or standard technologies that may be available or known now orat any time in the future. Similarly, the plural may in some cases berecognized as applicable to the singular and vice versa. Likewise, wherethis document refers to technologies that would be apparent or known toone of ordinary skill in the art, such technologies encompass thoseapparent or known to the skilled artisan now or at any time in thefuture.

The presence of broadening words and phrases such as “one or more,” “atleast,” “but not limited to” or other like phrases in some instancesshall not be read to mean that the narrower case is intended or requiredin instances where such broadening phrases may be absent. The use of theterm “module” does not imply that the components or functionalitydescribed or claimed as part of the module are all configured in acommon package. Indeed, any or all of the various components of amodule, whether control logic, circuitry, or other components, may becombined in a single package or separately maintained and may further bedistributed in multiple groupings or packages or across multiplelocations.

Additionally, the various embodiments set forth herein are described interms of example block diagrams, flow charts, and other illustrations.As will become apparent to one of ordinary skill in the art afterreading this document, the illustrated embodiments and their variousalternatives may be implemented without confinement to the illustratedexamples. For example, block diagrams and their accompanying descriptionshould not be construed as mandating a particular architecture orconfiguration. Moreover, the operations and sub-operations of variousmethods described herein are not necessarily limited to the orderdescribed or shown in the figures, and one of skill in the art willappreciate, upon studying the present disclosure, variations of theorder of the operations described herein that are within the spirit andscope of the disclosure.

In addition, the operations and sub-operations of methods describedherein may be carried out or implemented, in some cases, by one or moreof the components, elements, devices, modules, circuitry, processors,etc. of systems, apparatuses, devices, environments, and/or computingmodules described herein and referenced in various of FIGS. of thepresent disclosure, as well as one or more sub-components, elements,devices, modules, processors, circuitry, and the like depicted thereinand/or described with respect thereto. In such instances, thedescription of the methods or aspects thereof may refer to acorresponding component, element, etc., but regardless of whether anexplicit reference is made, one of skill in the art will recognize uponstudying the present disclosure when the corresponding component,element, etc. may be used. Further, it will be appreciated that suchreferences do not necessarily limit the described methods to theparticular component, element, etc. referred to. Thus, it will beappreciated by one of skill in the art that aspects and featuresdescribed above in connection with (sub-) components, elements, devices,modules, and circuitry, etc., including variations thereof, may beapplied to the various operations described in connection with methodsdescribed herein, and vice versa, without departing from the scope ofthe present disclosure.

What is claimed is:
 1. A method of using a diabetes management partnerinterface to configure an analyte sensor system for wirelesscommunication with a plurality of partner devices, the methodcomprising: the analyte sensor system receiving authorization to provideone of the plurality of partner devices with access to a set ofconfiguration parameters via the diabetes management partner interface,wherein the set of configuration parameters is stored in a memory of theanalyte sensor system; and responsive to input received from the one ofthe plurality of partner devices via the diabetes management partnerinterface, the analyte sensor system setting or causing a modificationto the set of configuration parameters, according to a systemrequirement of the one of the plurality of partner devices.
 2. Themethod of claim 1, wherein the one of the plurality of partner devicesis an automatic insulin delivery device or a manual insulin deliverydevice.
 3. The method of claim 1, wherein the set of configurationparameters comprises one or more of a set of wireless connectivityparameters, a set of access control parameters, and a set of analytedata parameters.
 4. The method of claim 1, wherein the systemrequirement is associated with one of: a battery capacity of the one ofthe plurality of partner devices; an accuracy requirement of the one ofthe plurality of partner devices; a communication protocol used by theone of the plurality of partner devices; a regulatory requirementapplicable to the one of the plurality of partner devices; and anexpected operational time of the one of the plurality of partnerdevices.
 5. The method of claim 3, wherein: the set of wirelessconnectivity parameters comprises a condition under which the one of theplurality of partner devices is to be removed from a whitelistmaintained for the analyte sensor system; and the analyte sensor systemsetting or causing the modification to the set of configurationparameters according to the system requirement of the one of theplurality of partner devices comprises the analyte sensor system settingthe condition such that the one of the plurality of partner devices isto be removed from the whitelist when a battery level of the one of theplurality of partner devices meets a threshold.
 6. The method of claim3, wherein: the set of wireless connectivity parameters comprises anadvertisement structure; and the analyte sensor system setting orcausing the modification to the set of configuration parametersaccording to the system requirement of the one of the plurality ofpartner devices comprises the analyte sensor system using the diabetesmanagement partner interface to set or modify the advertisementstructure.
 7. The method of claim 3, wherein the set of access controlparameters comprises one or more of: a number of display devices thatthe analyte sensor system may connect to; and a level of access orcontrol the analyte sensor system may give to one or more of the displaydevices.
 8. The method of claim 3, wherein: the set of analyte dataparameters comprises a calibration period for the analyte sensor system;and the analyte sensor system setting or causing the modification to theset of configuration parameters according to the system requirement ofthe one of the plurality of partner devices comprises the analyte sensorsystem using the diabetes management partner interface to set or modifythe calibration period.
 9. The method of claim 8, wherein: the set ofanalyte data parameters comprises a factory calibration code; theanalyte sensor system uses the diabetes management partner interface toreceive from the one of the plurality of partner devices an indicationto use the factory calibration code, according to the system requirementof the one of the plurality of partner devices; and the analyte sensorsystem setting or causing the modification to the set of configurationparameters according to the system requirement of the one of theplurality of partner devices comprises the analyte sensor system usingthe diabetes management partner interface to set or modify thecalibration period to zero or none.
 10. The method of claim 3, whereinthe set of wireless connectivity parameters comprises settings in aremote server, wherein the analyte sensor system setting or causing themodification to the set of configuration parameters according to thesystem requirement of the one of the plurality of partner devicescomprises using the diabetes management partner interface to configurethe analyte sensor to: use services provided via the remote server;responsive to services provided via the remote server, transmit diabetesmanagement feedback to one or more display devices connected to theanalyte sensor system; and if the services provided via the remoteserver become unavailable, disable the use of the services and send arelated notification to display devices connected to the analyte sensorsystem.
 11. The method of claim 10, wherein: the set of analyte dateparameters comprises bolus calculation parameters; and the analytesensor system setting or causing the modification to the set ofconfiguration parameters according to the system requirement of the oneof the plurality of partner devices comprises the analyte sensor systemusing the diabetes management partner interface to provide the one ofthe plurality of partner devices with access to the bolus calculationparameters.
 12. The method of claim 11, further comprising the analytesensor system providing a bolus recommendation based on a calculationperformed using the bolus calculation parameters.
 13. A system,comprising: one or more partner devices adapted to deliver insulin to auser; an analyte sensor system adapted to generate analyte information,the analyte sensor system comprising a set of configuration parametersused to transmit and receive wireless signals, wherein the configurationparameters are configurable by use of a diabetes management partnerinterface; and a display device connectable to the analyte sensor systemand adapted to display analyte information and to provide authorizationfor the analyte sensor system to provide one of the one or more partnerdevices with access to the set of configuration parameters via thediabetes management partner interface; wherein the one of the one ormore partner devices is adapted to use the diabetes management partnerinterface to set or cause a modification to the set of configurationparameters, according to a system requirement of the one of the one ormore partner devices.
 14. The system of claim 13, wherein the one of theone or more partner devices is an automatic insulin delivery device or amanual insulin delivery device.
 15. The system of claim 13, wherein theset of configuration parameters comprises one or more of a set ofwireless connectivity parameters, a set of access control parameters,and a set of analyte data parameters.
 16. The system of claim 13,wherein the system requirement is associated with one of: a batterycapacity of the one of the one or more partner devices; an accuracyrequirement of the one of the one or more partner devices; acommunication protocol used by the one of the one or more partnerdevices; a regulatory requirement applicable to the one of the one ormore partner devices; and an expected operational time of the one of theone or more partner devices.
 17. The system of claim 15, wherein: theset of wireless connectivity parameters comprises a condition underwhich the one of the one or more partner devices is to be removed from awhitelist maintained for the analyte sensor system; and the one of theone or more partner devices is further adapted use the diabetesmanagement partner interface to set or modify the condition such thatthe one of the one or more partner devices is to be removed from thewhitelist when a battery level of the one of the one or more partnerdevices meets a threshold, according to the system requirement of theone of the one or more partner devices.
 18. The system of claim 15,wherein: the set of wireless connectivity parameters comprises anadvertisement structure; and the one of the one or more partner devicesis further adapted to use the diabetes management partner interface toset or modify the advertisement structure.
 19. The system of claim 15,wherein the set of access control parameters comprises one or more of: anumber of display devices that the analyte sensor system may connect to;and a level of access or control the analyte sensor system may give toone or more of the display devices.
 20. The system of claim 15, wherein:the set of analyte data parameters comprises a calibration period forthe analyte sensor system; and the one of the one or more partnerdevices is further adapted to use the diabetes management partnerinterface to set or modify the calibration period.
 21. The system ofclaim 20, wherein: the set of analyte data parameters comprises afactory calibration code; and the one of the one or more partner devicesis further adapted to use the diabetes management partner interface to:provide the analyte sensor system with an indication to use the factorycalibration code, according to the system requirement of the one of theone or more partner devices; and to set or modify the calibration periodto zero or none.
 22. The system of claim 15, wherein: the set ofwireless connectivity parameters comprises settings in a remote server;and the one of the one or more partner devices is further adapted to usethe diabetes management partner interface to configure the analytesensor to: use services provided via the remote server; responsive toservices provided via the remote server, transmit diabetes managementfeedback to display device connectable to the analyte sensor system; andif the services provided via the remote server become unavailable,disable the use of the services and send a related notification to thedisplay device connectable to the analyte sensor system.
 23. The systemof claim 22, wherein: the set of analyte date parameters comprises boluscalculation parameters; and the one of the one or more partner devicesis further adapted to use the diabetes management partner interface toconfigure the analyte sensor system to provide the one of the one ormore partner devices with access to the bolus calculation parameters,according to the system requirement of the one of the one or morepartner devices.
 24. The system of claim 23, wherein the one of the oneor more partner devices is further adapted to use the diabetesmanagement partner interface receive from the analyte sensor system abolus recommendation based on a calculation performed using the boluscalculation parameters.
 25. A method comprising: establishing aconnection between a display device and an analyte sensor system; thedisplay device receiving an indication that the analyte sensor system isconnecting to a partner device; after receiving authorization to providethe partner device with access to a set of configuration parameters viaa diabetes management partner interface, receiving, via the diabetesmanagement partner interface, configuration parameters for alertsoriginating from the partner device; the display device providing a userinterface to configure alerts originating from the analyte sensor systemand the alerts originating from the partner device; and using inputreceived via the user interface to cause a modification to theconfiguration parameters for the alerts originating from the partnerdevice, wherein the modification is made in accordance with a systemrequirement of the partner device.
 26. The method of claim 25, furthercomprising receiving, via the user interface, a selection of the partnerdevice or a remote device of a plurality of remote devices thatcomprises the display device, to be used as a primary device forproviding one or more of the alerts originating from the analyte sensorsystem and the alerts originating from the partner device.
 27. Themethod of claim 26, further comprising providing the alerts on a deviceother than the primary device in the event a battery capacity of theprimary device falls below a threshold.
 28. The method of claim 25,further comprising the display device receiving, via the user interface,a selection of respective alerts types to be provided for the alertsoriginating from the partner device and for the alerts originating fromthe analyte sensor system.
 29. The method of claim 25, furthercomprising: providing the alerts via a primary notification device; andif no acknowledgment is received in response to providing the alerts viathe primary notification device, providing the alerts via a secondarynotification device, wherein the primary and secondary notificationdevices are selected from the group consisting of the partner device,the analyte sensor system, and at least one of the plurality of remotedevices.